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NCT03456076 · OUTCOME

Plasma Concentration of Alectinib

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
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose (2 hours) Week 3 - Week 96

Analysis population: The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.

Groups in this outcome

Alectinib

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

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

Analysis denominator · Participants

GroupSource count
Alectinib124

Reported measurements

Week 3

Analysis denominator · Participants

GroupSource count
Alectinib118
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib382276.2Not reportedNot reportedNot reported
Week 6

Analysis denominator · Participants

GroupSource count
Alectinib116
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib61170.6Not reportedNot reportedNot reported
Week 9

Analysis denominator · Participants

GroupSource count
Alectinib114
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib59391.4Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
Alectinib113
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib58194.9Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Alectinib111
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib61993.2Not reportedNot reportedNot reported
Week 36

Analysis denominator · Participants

GroupSource count
Alectinib107
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib63954.1Not reportedNot reportedNot reported
Week 48

Analysis denominator · Participants

GroupSource count
Alectinib103
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib55190.1Not reportedNot reportedNot reported
Week 60

Analysis denominator · Participants

GroupSource count
Alectinib102
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib58858.9Not reportedNot reportedNot reported
Week 72

Analysis denominator · Participants

GroupSource count
Alectinib97
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib52796.5Not reportedNot reportedNot reported
Week 84

Analysis denominator · Participants

GroupSource count
Alectinib81
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib51591.1Not reportedNot reportedNot reported
Week 96

Analysis denominator · Participants

GroupSource count
Alectinib68
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib478106.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        276.2
        value
        382
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      units
      Participants
    title
    Week 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.6
        value
        611
    denoms
    1. counts
      1. group Id
        OG000
        value
        116
      units
      Participants
    title
    Week 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        91.4
        value
        593
    denoms
    1. counts
      1. group Id
        OG000
        value
        114
      units
      Participants
    title
    Week 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.9
        value
        581
    denoms
    1. counts
      1. group Id
        OG000
        value
        113
      units
      Participants
    title
    Week 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        93.2
        value
        619
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      units
      Participants
    title
    Week 24
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.1
        value
        639
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      units
      Participants
    title
    Week 36
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        90.1
        value
        551
    denoms
    1. counts
      1. group Id
        OG000
        value
        103
      units
      Participants
    title
    Week 48
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.9
        value
        588
    denoms
    1. counts
      1. group Id
        OG000
        value
        102
      units
      Participants
    title
    Week 60
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        96.5
        value
        527
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    Week 72
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        91.1
        value
        515
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Week 84
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        106.4
        value
        478
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Week 96
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 600 mg oral alectinib twice daily (BID) for 2 years
    id
    OG000
    title
    Alectinib
param Type
GEOMETRIC_MEAN
population Description
The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.
reporting Status
POSTED
time Frame
Predose (2 hours) Week 3 - Week 96
title
Plasma Concentration of Alectinib
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice