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NCT02281084 · OUTCOME

Kaplan-Meier Estimate of Onset to Achieve Stable Disease

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
Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms

What was measured

A participant was considered as having a stable disease if the disease neither responded nor progressed during or after study treatment.

Analysis population: Includes all participants in the ITT population with progressive disease at baseline and achieved stable disease; those who didn't achieve SD or better were censored.

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 Azacitidine0
Progressive Disease (PD) Cohort: Oral Azacitidine22
Stable Disease Cohort: Oral Azacitidine and Durvalumab0
Progressive Disease Cohort: Oral Azacitidine and Durvalumab5

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Progressive Disease (PD) Cohort: Oral AzacitidineNANot reported1.74NACould not be estimated due to the insufficient number of events
Progressive Disease Cohort: Oral Azacitidine and DurvalumabNANot 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
        OG001
        lower Limit
        1.74
        upper Limit
        NA
        value
        NA
      2. comment
        Could not be estimated due to the insufficient number of events
        group Id
        OG003
        lower Limit
        1.64
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      22
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      5
    units
    Participants
description
A participant was considered as having a stable disease if the disease neither responded nor progressed during or after study treatment.
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
Includes all participants in the ITT population with progressive disease at baseline and achieved stable disease; those who didn't achieve SD or better were censored.
reporting Status
POSTED
time Frame
Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms
title
Kaplan-Meier Estimate of Onset to Achieve Stable Disease
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice