NCT02807636 · OUTCOME

Percentage of Participants With Atezolizumab-Specific Adverse Events of Special Interest (AESIs)

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 atezolizumab-specific Adverse Events of Special Interest (AESIs) 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

Group	Source count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin	454
Placebo+Gemcitabine+Carboplatin/Cisplatin	389
Atezolizumab Monotherapy	354

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin	53.3	Not reported	Not reported	Not reported	Not reported
Placebo+Gemcitabine+Carboplatin/Cisplatin	35.5	Not reported	Not reported	Not reported	Not reported
Atezolizumab Monotherapy	39.5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
53.3
group Id
OG001
value
35.5
group Id
OG002
value
39.5

denoms

counts
group Id
OG000
value
454
group Id
OG001
value
389
group Id
OG002
value
354
units
Participants

description

Percentage of participants with atezolizumab-specific Adverse Events of Special Interest (AESIs) Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

groups

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
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
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 Atezolizumab-Specific Adverse Events of Special Interest (AESIs)

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice