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NCT00946647 · OUTCOME

1-year Survival Rate (Phase Llb)

A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). · Source last updated 2020-08-04

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
12 months

What was measured

Overall survival was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Patients not known to have died were censored for 'Lost to follow-up' if the time between their last contact date and the analysis cut-off date was longer than 3 months and 2 weeks (104 days) during the first year after study evaluation completion, and longer than 6 months and 2 weeks (194 days), thereafter. The 1-year survival rate was obtained from the Kaplan-Meier analysis of overall survival, and its variance was estimated by Greenwood's formula.

Analysis population: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms

Groups in this outcome

Panobinostat + 5-Azacytidine

In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.

5-Azacytidine

The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.

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

Analysis denominator · Participants

GroupSource count
Panobinostat + 5-Azacytidine40
5-Azacytidine42

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + 5-Azacytidine14.9Not reported10.4NANA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
5-Azacytidine15.6Not reported11.4NANA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
        group Id
        OG000
        lower Limit
        10.4
        upper Limit
        NA
        value
        14.9
      2. comment
        NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
        group Id
        OG001
        lower Limit
        11.4
        upper Limit
        NA
        value
        15.6
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      42
    units
    Participants
description
Overall survival was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Patients not known to have died were censored for 'Lost to follow-up' if the time between their last contact date and the analysis cut-off date was longer than 3 months and 2 weeks (104 days) during the first year after study evaluation completion, and longer than 6 months and 2 weeks (194 days), thereafter. The 1-year survival rate was obtained from the Kaplan-Meier analysis of overall survival, and its variance was estimated by Greenwood's formula.
dispersion Type
95% Confidence Interval
groups
  1. description
    In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
    id
    OG000
    title
    Panobinostat + 5-Azacytidine
  2. description
    The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
    id
    OG001
    title
    5-Azacytidine
param Type
MEDIAN
population Description
Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
reporting Status
POSTED
time Frame
12 months
title
1-year Survival Rate (Phase Llb)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice