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NCT00982111 · OUTCOME

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin · Source last updated 2022-01-11

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

Measure
GEOMETRIC_MEAN
Unit
micrograms/milliliter (ug/ml)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks

Analysis population: Participants who were randomized to necitumumab and had evaluable PK data.

Groups in this outcome

Necitumumab + Pemetrexed + Cisplatin

Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

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

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin315

Reported measurements

Predose Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin222
Values in micrograms/milliliter (ug/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin57.584.5Not reportedNot reportedNot reported
Predose Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin185
Values in micrograms/milliliter (ug/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin80.889.3Not reportedNot reportedNot reported
Predose Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin159
Values in micrograms/milliliter (ug/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin11082.9Not reportedNot reportedNot reported
Predose Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin131
Values in micrograms/milliliter (ug/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin11581.8Not reportedNot reportedNot reported
Predose Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin110
Values in micrograms/milliliter (ug/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin11968.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.5
        value
        57.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        222
      units
      Participants
    title
    Predose Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.3
        value
        80.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      units
      Participants
    title
    Predose Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.9
        value
        110
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      units
      Participants
    title
    Predose Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        81.8
        value
        115
    denoms
    1. counts
      1. group Id
        OG000
        value
        131
      units
      Participants
    title
    Predose Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.9
        value
        119
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      units
      Participants
    title
    Predose Cycle 6 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      315
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    OG000
    title
    Necitumumab + Pemetrexed + Cisplatin
param Type
GEOMETRIC_MEAN
population Description
Participants who were randomized to necitumumab and had evaluable PK data.
reporting Status
POSTED
time Frame
Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks
title
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
type
SECONDARY
unit Of Measure
micrograms/milliliter (ug/ml)

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Preserved source evidence · Not medical advice