Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01327053 · OUTCOME

Overall Survival (OS)

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Source last updated 2019-08-28

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
42 months

What was measured

OS is defined as the time from date of randomization to date of death due to any cause or the last date that a patient was known to be alive (censored observation) as of the data cut-off.

Analysis population: The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.

Groups in this outcome

LDE225 200mg laBCC

The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 800mg laBCC

The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 200mg mBCC

The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 800mg mBCC

The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
LDE225 200mg laBCC66
LDE225 800mg laBCC128
LDE225 200mg mBCC13
LDE225 800mg mBCC23

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
LDE225 200mg laBCCNANot reportedNANAN/A = Median OS was non-estimable for patients with laBCC receiving treatment with sonidegib 200 mg as limited number of deaths were observed.
LDE225 800mg laBCCNANot reportedNANAN/A = Median OS was non-estimable for patients with laBCC receiving treatment with sonidegib 800 mg as limited number of deaths were observed.
LDE225 200mg mBCC47.6Not reportedNANAN/A = Both lower and upper confidence intervals were not estimable as limited number of deaths were observed.
LDE225 800mg mBCC33.8Not reportedNANAN/A = Both lower and upper confidence intervals were not estimable as limited number of deaths were observed.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A = Median OS was non-estimable for patients with laBCC receiving treatment with sonidegib 200 mg as limited number of deaths were observed.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        N/A = Median OS was non-estimable for patients with laBCC receiving treatment with sonidegib 800 mg as limited number of deaths were observed.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        N/A = Both lower and upper confidence intervals were not estimable as limited number of deaths were observed.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        47.6
      4. comment
        N/A = Both lower and upper confidence intervals were not estimable as limited number of deaths were observed.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        33.8
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      128
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      23
    units
    Participants
description
OS is defined as the time from date of randomization to date of death due to any cause or the last date that a patient was known to be alive (censored observation) as of the data cut-off.
dispersion Type
95% Confidence Interval
groups
  1. description
    The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    OG000
    title
    LDE225 200mg laBCC
  2. description
    The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    OG001
    title
    LDE225 800mg laBCC
  3. description
    The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    OG002
    title
    LDE225 200mg mBCC
  4. description
    The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    OG003
    title
    LDE225 800mg mBCC
param Type
MEDIAN
population Description
The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.
reporting Status
POSTED
time Frame
42 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice