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NCT02281084 · OUTCOME

Kaplan-Meier Estimate of Time to Progression to AML

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes · Source last updated 2024-10-04

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose and until death, loss to follow-up, withdrawal of consent for further data collection (Up to 91 months)

What was measured

Time to AML progression was defined as the time from the date of first dose of IP until the date the participant had documented progression to AML.

Analysis population: The ITT population included all enrolled participants who received at least one dose of investigational product (IP).

Groups in this outcome

Stable Disease (SD) Cohort: Oral Azacitidine

Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Progressive Disease (PD) Cohort: Oral Azacitidine

Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Stable Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Progressive Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

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

Analysis denominator · Participants

GroupSource count
Stable Disease (SD) Cohort: Oral Azacitidine32
Progressive Disease (PD) Cohort: Oral Azacitidine22
Stable Disease Cohort: Oral Azacitidine and Durvalumab6
Progressive Disease Cohort: Oral Azacitidine and Durvalumab5

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stable Disease (SD) Cohort: Oral AzacitidineNANot reported12.89NACould not be estimated due to the insufficient number of events.
Progressive Disease (PD) Cohort: Oral AzacitidineNANot reported8.42NACould not be estimated due to the insufficient number of events.
Stable Disease Cohort: Oral Azacitidine and Durvalumab21.47Not reported1.68NACould not be estimated due to the insufficient number of events.
Progressive Disease Cohort: Oral Azacitidine and Durvalumab6.21Not reported1.64NACould not be estimated due to the insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG000
        lower Limit
        12.89
        upper Limit
        NA
        value
        NA
      2. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG001
        lower Limit
        8.42
        upper Limit
        NA
        value
        NA
      3. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG002
        lower Limit
        1.68
        upper Limit
        NA
        value
        21.47
      4. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG003
        lower Limit
        1.64
        upper Limit
        NA
        value
        6.21
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      22
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      5
    units
    Participants
description
Time to AML progression was defined as the time from the date of first dose of IP until the date the participant had documented progression to AML.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG000
    title
    Stable Disease (SD) Cohort: Oral Azacitidine
  2. description
    Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG001
    title
    Progressive Disease (PD) Cohort: Oral Azacitidine
  3. description
    Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG002
    title
    Stable Disease Cohort: Oral Azacitidine and Durvalumab
  4. description
    Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG003
    title
    Progressive Disease Cohort: Oral Azacitidine and Durvalumab
param Type
MEDIAN
population Description
The ITT population included all enrolled participants who received at least one dose of investigational product (IP).
reporting Status
POSTED
time Frame
From first dose and until death, loss to follow-up, withdrawal of consent for further data collection (Up to 91 months)
title
Kaplan-Meier Estimate of Time to Progression to AML
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice