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NCT02366143 · OUTCOME

Cmax of Bevacizumab in Arm B and Arm C

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23

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

Measure
MEAN
Unit
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)

Analysis population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Groups in this outcome

Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)

Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Arm C (Bevacizumab+Paclitaxel+Carboplatin)

Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

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

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)205
Arm C (Bevacizumab+Paclitaxel+Carboplatin)215

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)205
Arm C (Bevacizumab+Paclitaxel+Carboplatin)215
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)329129Not reportedNot reportedNot reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)32395.0Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)154
Arm C (Bevacizumab+Paclitaxel+Carboplatin)168
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)413126Not reportedNot reportedNot reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)430123Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        129
        value
        329
      2. group Id
        OG001
        spread
        95.0
        value
        323
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        215
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        126
        value
        413
      2. group Id
        OG001
        spread
        123
        value
        430
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        168
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      215
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
    id
    OG000
    title
    Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
  2. description
    Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
    id
    OG001
    title
    Arm C (Bevacizumab+Paclitaxel+Carboplatin)
param Type
MEAN
population Description
The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)
title
Cmax of Bevacizumab in Arm B and Arm C
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice