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NCT00103285 · OUTCOME

Event-free Survival (EFS) for SR-High Patients.

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2021-06-14

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

Measure
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
6 years

What was measured

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.

Analysis population: CCR: Complete Continuous Remission, where time to event is defined as the time from start of consolidation therapy to first event or date of last follow up for those who did not experience an event. All patients enrolled on the SR-High were used in this analysis regardless of completion of therapy.

Groups in this outcome

Group 3-SR-high ALL, Combination Chemotherapy

Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium, and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine,MTX. Patients with DS receive (dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT 3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 3-SR-high ALL, Combination Chemotherapy636

Reported measurements

Source class 1
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 3-SR-high ALL, Combination Chemotherapy85.58Not reported85.5585.61Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        85.55
        upper Limit
        85.61
        value
        85.58
denoms
  1. counts
    1. group Id
      OG000
      value
      636
    units
    Participants
description
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, methotrexate. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (2 courses - vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium, and augmented DI therapy (2 courses - vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine,MTX. Patients with DS receive (dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT 3-dimensional conformal radiation therapy: Some patients undergo cranial radiotherapy cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO
    id
    OG000
    title
    Group 3-SR-high ALL, Combination Chemotherapy
param Type
NUMBER
population Description
CCR: Complete Continuous Remission, where time to event is defined as the time from start of consolidation therapy to first event or date of last follow up for those who did not experience an event. All patients enrolled on the SR-High were used in this analysis regardless of completion of therapy.
reporting Status
POSTED
time Frame
6 years
title
Event-free Survival (EFS) for SR-High Patients.
type
SECONDARY
unit Of Measure
percent probability

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

Preserved source evidence · Not medical advice