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NCT01077544 · OUTCOME

Efficacy Endpoints for Ph+ ALL Patients

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-12-29

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
minimum of 12 cycles (28 days per cycle)

What was measured

Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.

Analysis population: Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.

Groups in this outcome

Group 1

1 year to \< 10 years pediatric patients

Group 2

\>= 10 years to \<18 years pediatric patients

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 13
Group 21

Reported measurements

Complete Remission with platelet recovery
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 12Not reportedNot reportedNot reportedNot reported
Group 21Not reportedNot reportedNot reportedNot reported
Complete Remission w/incomplete platelet recovery
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 10Not reportedNot reportedNot reportedNot reported
Group 20Not reportedNot reportedNot reportedNot reported
Partial remission
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 10Not reportedNot reportedNot reportedNot reported
Group 20Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 11Not reportedNot reportedNot reportedNot reported
Group 20Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 10Not reportedNot reportedNot reportedNot reported
Group 20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Complete Remission with platelet recovery
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Remission w/incomplete platelet recovery
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Partial remission
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Stable disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.
groups
  1. description
    1 year to \< 10 years pediatric patients
    id
    OG000
    title
    Group 1
  2. description
    \>= 10 years to \<18 years pediatric patients
    id
    OG001
    title
    Group 2
param Type
NUMBER
population Description
Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.
reporting Status
POSTED
time Frame
minimum of 12 cycles (28 days per cycle)
title
Efficacy Endpoints for Ph+ ALL Patients
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice