Skip to content
← Full study record

NCT03038100 · OUTCOME

Maximum Serum Concentration (Cmax) of Atezolizumab

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2023-02-17

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

Measure
MEAN
Unit
µg/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose

Analysis population: PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.

Groups in this outcome

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 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
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab538

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab538
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab487163Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab499
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab614209Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        163
        value
        487
    denoms
    1. counts
      1. group Id
        OG000
        value
        538
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        209
        value
        614
    denoms
    1. counts
      1. group Id
        OG000
        value
        499
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      538
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    id
    OG000
    title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
param Type
MEAN
population Description
PK-evaluable population is defined as patients who received any dose of study medication and who had at least one post-baseline PK sample available.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
title
Maximum Serum Concentration (Cmax) of Atezolizumab
type
SECONDARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice