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NCT03038100 · OUTCOME

Percentage of Participants With at Least One Adverse Event

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
NUMBER
Unit
Percentage
Interval / dispersion
Not reported
Time frame
From randomization up to approximately 59 months

What was measured

Percentage of participants with at least one adverse event.

Analysis population: Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).

Groups in this outcome

Placebo With Paclitaxel, Carboplatin and Bevacizumab

Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo 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 placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo 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 placebo for additional 16 cycles.

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
Placebo With Paclitaxel, Carboplatin and Bevacizumab644
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab642

Reported measurements

Source class 1
Values in Percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo With Paclitaxel, Carboplatin and Bevacizumab99.8Not reportedNot reportedNot reportedNot reported
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        99.8
      2. group Id
        OG001
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      644
    2. group Id
      OG001
      value
      642
    units
    Participants
description
Percentage of participants with at least one adverse event.
groups
  1. description
    Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo 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 placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo 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 placebo for additional 16 cycles.
    id
    OG000
    title
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
  2. 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
    OG001
    title
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
param Type
NUMBER
population Description
Safety-evaluable population is defined as patients who received any amount of any study treatment (atezolizumab, placebo, paclitaxel, carboplatin, or bevacizumab).
reporting Status
POSTED
time Frame
From randomization up to approximately 59 months
title
Percentage of Participants With at Least One Adverse Event
type
SECONDARY
unit Of Measure
Percentage

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

Preserved source evidence · Not medical advice