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NCT01828099 · OUTCOME

All Collected Deaths

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Pre-treatment: up to 28 days; On-Treatment: up to approx. 120 months; Extension-treatment: up to approx. 108 months; Post-treatment: up to approx. 120 months

What was measured

Pre-treatment: From randomization to start of treatment. On-Treatment: From start of treatment to 30 days post-treatment or start of crossover treatment. Extension-treatment: From start of crossover treatment to 30 days post-crossover treatment. Post-treatment: From 31 days after last dose of treatment to the end of study.

Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. For the Chemotherapy/Ceritinib group, the analysis included patients randomized to the chemotherapy arm who crossed over and received at least one dose of ceritinib

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

Chemotherapy

Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

Chemotherapy to Ceritinib

Patients randomized to chemotherapy who crossed over to ceritinib at the extension-treatment period

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

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy187
Chemotherapy to Ceritinib100

Reported measurements

Pre-treatment

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy187
Chemotherapy to Ceritinib0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ceritinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy3Not reportedNot reportedNot reportedNot reported
Chemotherapy to Ceritinib0Not reportedNot reportedNot reportedNot reported
On-Treatment

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy175
Chemotherapy to Ceritinib100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ceritinib15Not reportedNot reportedNot reportedNot reported
Chemotherapy7Not reportedNot reportedNot reportedNot reported
Chemotherapy to Ceritinib15Not reportedNot reportedNot reportedNot reported
Post-treatment

Analysis denominator · Participants

GroupSource count
Ceritinib149
Chemotherapy60
Chemotherapy to Ceritinib83
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ceritinib98Not reportedNot reportedNot reportedNot reported
Chemotherapy38Not reportedNot reportedNot reportedNot reported
Chemotherapy to Ceritinib56Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Ceritinib189
Chemotherapy187
Chemotherapy to Ceritinib100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ceritinib113Not reportedNot reportedNot reportedNot reported
Chemotherapy48Not reportedNot reportedNot reportedNot reported
Chemotherapy to Ceritinib71Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        187
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Pre-treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        175
      3. group Id
        OG002
        value
        100
      units
      Participants
    title
    On-Treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        56
    denoms
    1. counts
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        60
      3. group Id
        OG002
        value
        83
      units
      Participants
    title
    Post-treatment
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        113
      2. group Id
        OG001
        value
        48
      3. group Id
        OG002
        value
        71
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        187
      3. group Id
        OG002
        value
        100
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    2. group Id
      OG001
      value
      187
    3. group Id
      OG002
      value
      100
    units
    Participants
description
Pre-treatment: From randomization to start of treatment. On-Treatment: From start of treatment to 30 days post-treatment or start of crossover treatment. Extension-treatment: From start of crossover treatment to 30 days post-crossover treatment. Post-treatment: From 31 days after last dose of treatment to the end of study.
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
  2. description
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    id
    OG001
    title
    Chemotherapy
  3. description
    Patients randomized to chemotherapy who crossed over to ceritinib at the extension-treatment period
    id
    OG002
    title
    Chemotherapy to Ceritinib
param Type
COUNT_OF_PARTICIPANTS
population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. For the Chemotherapy/Ceritinib group, the analysis included patients randomized to the chemotherapy arm who crossed over and received at least one dose of ceritinib
reporting Status
POSTED
time Frame
Pre-treatment: up to 28 days; On-Treatment: up to approx. 120 months; Extension-treatment: up to approx. 108 months; Post-treatment: up to approx. 120 months
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