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NCT01844765 · OUTCOME

All Collected Deaths

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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
approx. 64.5 months, approx. 7 years

What was measured

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 64.5 months (treatment duration ranged from 0.7 to 63.5 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approx. 7 years.

Analysis population: Clinical Database Population: All treated participants.

Groups in this outcome

Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

Newly Diagnosed and Untreated Ph+ CML in First CP

Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.

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

Analysis denominator · Participants

GroupSource count
Resistant/Intolerant Ph+ CML in CP33
Newly Diagnosed and Untreated Ph+ CML in First CP25

Reported measurements

On-treatment deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP0Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP0Not reportedNot reportedNot reportedNot reported
Total Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Resistant/Intolerant Ph+ CML in CP1Not reportedNot reportedNot reportedNot reported
Newly Diagnosed and Untreated Ph+ CML in First CP3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    On-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Total Deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      25
    units
    Participants
description
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 64.5 months (treatment duration ranged from 0.7 to 63.5 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approx. 7 years.
groups
  1. description
    Patients resistant or intolerant to either imatinib or dasatinib
    id
    OG000
    title
    Resistant/Intolerant Ph+ CML in CP
  2. description
    Patients newly diagnosed in Chronic phase. Diagnosis within 6 months of date of first cytogenetic analysis confirming Philadelphia chromosome with (9;22) translocation by standard conventional cytogenetic analysis.
    id
    OG001
    title
    Newly Diagnosed and Untreated Ph+ CML in First CP
param Type
NUMBER
population Description
Clinical Database Population: All treated participants.
reporting Status
POSTED
time Frame
approx. 64.5 months, approx. 7 years
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice