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NCT02807636 · OUTCOME

Percentage of Participants With Serious Adverse Events (SAEs)

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2025-02-24

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 93 months

What was measured

Percentage of participants with Serious Adverse Events (SAEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Analysis population: The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.

Groups in this outcome

Atezolizumab+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Placebo+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Atezolizumab Monotherapy

Eligible participants received open-label atezolizumab as monotherapy.

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+Gemcitabine+Carboplatin/Cisplatin454
Placebo+Gemcitabine+Carboplatin/Cisplatin389
Atezolizumab Monotherapy354

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin53.7Not reportedNot reportedNot reportedNot reported
Placebo+Gemcitabine+Carboplatin/Cisplatin50.6Not reportedNot reportedNot reportedNot reported
Atezolizumab Monotherapy46.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        53.7
      2. group Id
        OG001
        value
        50.6
      3. group Id
        OG002
        value
        46.0
denoms
  1. counts
    1. group Id
      OG000
      value
      454
    2. group Id
      OG001
      value
      389
    3. group Id
      OG002
      value
      354
    units
    Participants
description
Percentage of participants with Serious Adverse Events (SAEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
groups
  1. description
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG000
    title
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
  2. description
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG001
    title
    Placebo+Gemcitabine+Carboplatin/Cisplatin
  3. description
    Eligible participants received open-label atezolizumab as monotherapy.
    id
    OG002
    title
    Atezolizumab Monotherapy
param Type
NUMBER
population Description
The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.
reporting Status
POSTED
time Frame
Baseline up to 93 months
title
Percentage of Participants With Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice