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NCT03456076 · OUTCOME

AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer · Source last updated 2026-07-15

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)

What was measured

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

Analysis population: The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.

Groups in this outcome

Alectinib

Participants received 600 mg oral alectinib twice daily (BID) for 2 years

Platinum-Based Chemotherapy

Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).

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

Analysis denominator · Participants

GroupSource count
Alectinib128
Platinum-Based Chemotherapy120

Reported measurements

Neutrophil count decreased
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib0Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy10.0Not reportedNot reportedNot reportedNot reported
Blood creatinine phosphokinase increased
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib6.3Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy0.8Not reportedNot reportedNot reportedNot reported
White blood cell count decreased
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib0Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy3.3Not reportedNot reportedNot reportedNot reported
Nausea
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib0Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy4.2Not reportedNot reportedNot reportedNot reported
Appendicitis
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib3.1Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy0Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib0Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy8.3Not reportedNot reportedNot reportedNot reported
Asthenia
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib0Not reportedNot reportedNot reportedNot reported
Platinum-Based Chemotherapy2.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10.0
    title
    Neutrophil count decreased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6.3
      2. group Id
        OG001
        value
        0.8
    title
    Blood creatinine phosphokinase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3.3
    title
    White blood cell count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4.2
    title
    Nausea
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3.1
      2. group Id
        OG001
        value
        0
    title
    Appendicitis
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        8.3
    title
    Neutropenia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.5
    title
    Asthenia
denoms
  1. counts
    1. group Id
      OG000
      value
      128
    2. group Id
      OG001
      value
      120
    units
    Participants
description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
groups
  1. description
    Participants received 600 mg oral alectinib twice daily (BID) for 2 years
    id
    OG000
    title
    Alectinib
  2. description
    Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
    id
    OG001
    title
    Platinum-Based Chemotherapy
param Type
NUMBER
population Description
The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.
reporting Status
POSTED
time Frame
Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
title
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice