Trial Outcomes & Findings for Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome (NCT NCT02521493)

Last Updated: 2025-08-01

Results Overview

The Kaplan-Meier method will be used to estimate 2-year EFS separately for standard risk and high risk patients. EFS is defined as the time from the end of Induction I to failure to achieve remission at the end of Induction II, relapse, occurrence of a second malignancy, or death.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

280 participants

Primary outcome timeframe

Up to 2 years from study entry

Results posted on

2025-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Standard Risk) Patients with MRD \<0.05% (This arm was closed to accrual and treatment with amendment #4A 01/07/2019)	Arm B (High Risk) Patients with MRD ≥ 0.05%	No Risk Stratification No Risk Stratification
Overall Study STARTED	114	44	122
Overall Study COMPLETED	89	38	0
Overall Study NOT COMPLETED	25	6	122

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Standard Risk) Patients with MRD \<0.05% (This arm was closed to accrual and treatment with amendment #4A 01/07/2019)	Arm B (High Risk) Patients with MRD ≥ 0.05%	No Risk Stratification No Risk Stratification
Overall Study Death	3	4	1
Overall Study Physician Decision	19	1	2
Overall Study Withdrawal by Subject	3	0	0
Overall Study Ineligible	0	1	0
Overall Study Post Amd4A (MRD < 0.05%)	0	0	115
Overall Study No MRD result	0	0	4

Baseline Characteristics

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Standard Risk) n=114 Participants Patients with MRD \<0.05% (This arm was closed to accrual and treatment with amendment #4A 01/07/2019)	Arm B (High Risk) n=44 Participants Patients with MRD ≥ 0.05%	No Risk Stratification n=122 Participants No Risk Stratification	Total n=280 Participants Total of all reporting groups
Age, Categorical <=18 years	114 Participants n=5 Participants	44 Participants n=7 Participants	122 Participants n=5 Participants	280 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	1.7 years STANDARD_DEVIATION 0.7 • n=5 Participants	1.7 years STANDARD_DEVIATION 0.6 • n=7 Participants	1.7 years STANDARD_DEVIATION 0.8 • n=5 Participants	1.7 years STANDARD_DEVIATION 0.7 • n=4 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	21 Participants n=7 Participants	61 Participants n=5 Participants	142 Participants n=4 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	23 Participants n=7 Participants	61 Participants n=5 Participants	138 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	3 Participants n=7 Participants	33 Participants n=5 Participants	66 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=5 Participants	33 Participants n=7 Participants	82 Participants n=5 Participants	193 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	24 Participants n=7 Participants	70 Participants n=5 Participants	166 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment United States	108 participants n=5 Participants	38 participants n=7 Participants	108 participants n=5 Participants	254 participants n=4 Participants
Region of Enrollment Canada	3 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	15 participants n=4 Participants
Region of Enrollment Australia	1 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment New Zealand	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Saudi Arabia	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 2 years from study entry

Population: The High Risk Arm excludes the following patients: 1 Ineligible, 1 withdrawal, 1 death prior to Induction II. The No Risk Stratification Arm had zero patients for induction II treatment, as all patients went off study at the end of Induction I

Outcome measures

Outcome measures
Measure	Arm A (Standard Risk) n=114 Participants Patients with MRD \<0.05% (This arm was closed to accrual and treatment with amendment #4A 01/07/2019)	Arm B (High Risk) n=41 Participants Patients with MRD ≥ 0.05%
Event-free Survival (EFS)	89.37 percentage of patients Interval 82.0 to 93.8	80.49 percentage of patients Interval 64.8 to 89.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from study entry

The mean number of days patients spent on protocol therapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 month from study entry

The proportion of patients experiencing an early death in the first month.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years from study entry

The Kaplan-Meier method will be used to estimate 2-year OS defined as the time from the end of Induction I to death.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from study entry

The proportion of patients experiencing a treatment related death will be reported along with a corresponding confidence interval.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years from study entry

The proportion of patients experiencing a relapse after achieving remission will be reported along with a corresponding confidence interval.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from study entry

The percentage of patients experiencing grade 3 or higher AEs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from study entry

The mean time to recovery of ANC to at least 1000/uL will be reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from study entry

Mean number of days patients are hospitalized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months from study entry

The proportion of patients having at least one infection will be reported.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Standard Risk)

Serious events: 3 serious events

Other events: 84 other events

Deaths: 12 deaths

Arm B (High Risk)

Serious events: 1 serious events

Other events: 37 other events

Deaths: 8 deaths

No Risk Stratification

Serious events: 2 serious events

Other events: 54 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (Standard Risk) n=114 participants at risk Patients with MRD \<0.05% (This arm was closed to accrual and treatment with amendment #4A 01/07/2019)	Arm B (High Risk) n=43 participants at risk Patients with MRD ≥ 0.05%	No Risk Stratification n=122 participants at risk No Risk Stratification
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.82% 1/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Alanine aminotransferase increased	0.88% 1/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Investigations Aspartate aminotransferase increased	0.88% 1/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Infections and infestations - Other, specify: Metapneumovirus	0.00% 0/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.82% 1/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Nervous system disorders Ischemia cerebrovascular	0.88% 1/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Lung infection	0.88% 1/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.82% 1/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
General disorders Multi-organ failure	0.00% 0/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.82% 1/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.88% 1/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Nervous system disorders Seizure	0.88% 1/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
Infections and infestations Sepsis	0.00% 0/114 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	2.3% 1/43 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.	0.00% 0/122 • While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 6264470064

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