Trial Outcomes & Findings for Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma (NCT NCT00335738)

NCT ID: NCT00335738

Last Updated: 2021-02-18

Results Overview

EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 331 participants
• Primary outcome timeframe: At 2 years
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Group 1 (Identified by Central Review as High Risk) Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Overall Study STARTED	108	223
Overall Study COMPLETED	97	219
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal

Measure	Group 1 (Identified by Central Review as High Risk) Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Overall Study Physician Decision	6	0
Overall Study Withdrawal by Subject	2	0
Overall Study Ineligible	3	4

Baseline Characteristics

Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma

Baseline characteristics by cohort

Measure	Group 1 (High Risk) n=108 Participants Patients receive liposomal vincristine sulfate IV aged based dosage (Pts \< 36 mos: 0.05 mg/kg, Pts \> 36 mos: 1.5 mg/m2, max dose 2 MG) given IV or infusion on day 1, carboplatin aged based dosage (Pts \< 36 mos: 18.6 mg/kg Pts \> 36 mos: 560 mg/m2) IV on day 1, and Etoposide aged based dosage (Pts \< 36 mos: 5 mg/kg, Pts \> 36 mos: 150 mg/m2) IV on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. liposomal vincristine sulfate: Given IV carboplatin: Given IV etoposide: Given IV	Group 2 (Not High Risk) n=223 Participants Patients undergo observation periodically for at least 5 years.	Total n=331 Participants Total of all reporting groups
Age, Continuous	2 years n=5 Participants	1 years n=7 Participants	2 years n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	107 Participants n=7 Participants	159 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	116 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	181 Participants n=7 Participants	263 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants	63 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	108 Participants n=7 Participants	151 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	34 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	144 participants n=7 Participants	209 participants n=5 Participants
Region of Enrollment New Zealand	1 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment India	32 participants n=5 Participants	55 participants n=7 Participants	87 participants n=5 Participants
Region of Enrollment Mexico	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Australia	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Bangladesh	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: At 2 years

Population: Only eligible patients are considered in the characterization of EFS at 2 years.

EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=89 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) n=235 Participants Patients undergo observation periodically for at least 5 years.
Event-free Survival (EFS)	0.9394 Estimated Probability Interval 0.8606 to 0.9743	0.9953 Estimated Probability Interval 0.9671 to 0.9993

PRIMARY outcome

Timeframe: At 2 Years

Population: Only eligible patients are considered for this outcome measure. This is calculated as the total number of patients enrolled in each group with the number ineligible in each group subtracted as reported on the participant flow template.

OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=89 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) n=235 Participants Patients undergo observation periodically for at least 5 years.
Overall Survival (OS)	0.9628 Estimated Probability Interval 0.889 to 0.9878	1 Estimated Probability Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: During planned six cycles of chemotherapy

Population: Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332.

Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=93 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	19 participants	—

SECONDARY outcome

Timeframe: At enrollment

Population: Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.

Proportion of patients who had posterior uveal invasion at enrollment.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=313 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)	0.24 Proportion of patients with PVI Interval 0.19 to 0.29	—

SECONDARY outcome

Timeframe: At enrollment

Population: Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.

Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=313 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding	0.16 Proportion of patients with LC Interval 0.12 to 0.21	—

SECONDARY outcome

Timeframe: At enrollment

Population: Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.

Proportion of patients that had scleral invasion at enrollment.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=313 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Pathological Features Present at Diagnosis - Scleral Invasion (SI)	0.016 Proportion of patients with SI Interval 0.0052 to 0.037	—

SECONDARY outcome

Timeframe: At enrollment

Population: Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.

Proportion of patients who had anterior chamber seeding at enrollment.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=313 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)	0.045 Proportion of patients with ACS Interval 0.025 to 0.074	—

SECONDARY outcome

Timeframe: At enrollment

Population: Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.

Proportion of patients who had iris infiltration at enrollment.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=313 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Pathological Features Present At Diagnosis - Iris Infiltration (II)	0.029 Proportion of patients with II Interval 0.013 to 0.054	—

SECONDARY outcome

Timeframe: At Enrollment

Population: Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow.

Proportion of patients who had ciliary body infiltration at enrollment.

Outcome measures

Measure	Group 1 (Identified by Central Review as High Risk) n=313 Participants Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)	0.019 Proportion of patients with CBI Interval 0.0071 to 0.041	—

Adverse Events

Group 1 (Identified by Central Review as High Risk)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Group 2 (Identified by Central Review as Not High Risk)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 (Identified by Central Review as High Risk) n=93 participants at risk Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.	Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.
Investigations Alanine aminotransferase increased	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Immune system disorders Anaphylaxis	5.4% 5/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Blood and lymphatic system disorders Anemia	2.2% 2/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Metabolism and nutrition disorders Anorexia	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Investigations Aspartate aminotransferase increased	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Gastrointestinal disorders Constipation	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Metabolism and nutrition disorders Dehydration	2.2% 2/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Gastrointestinal disorders Diarrhea	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Infections and infestations Enterocolitis infectious	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Infections and infestations Eye infection	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Blood and lymphatic system disorders Febrile neutropenia	9.7% 9/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Nervous system disorders Headache	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Infections and infestations Infections and infestations - Other, specify	2.2% 2/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Investigations Neutrophil count decreased	6.5% 6/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Infections and infestations Otitis media	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Investigations Platelet count decreased	4.3% 4/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.
Gastrointestinal disorders Vomiting	4.3% 4/93 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.	— 0/0 Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332 protocol.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 352-273-0567

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

• Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
• Publication restrictions are in place

Restriction type: OTHER