NCT02807636 · OUTCOME

OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

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
Interval / dispersion: 95% Confidence Interval
Time frame: Year 1

What was measured

Overall Survival (OS) Event Free Rate at 1 Year.

Analysis population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.

Groups in this outcome

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
Placebo+Gemcitabine+Carboplatin/Cisplatin	359
Atezolizumab Monotherapy	360

Reported measurements

Source class 1

Values in Percentage · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo+Gemcitabine+Carboplatin/Cisplatin	54.56	Not reported	49.23	59.88	Not reported
Atezolizumab Monotherapy	57.91	Not reported	52.72	63.10	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
-4.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.79
group Description
Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3761
param Type
Difference in Event Free Rate
param Value
3.36
statistical Method
Z-test

Complete source fields

analyses

ci Lower Limit
-4.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.79
group Description
Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3761
param Type
Difference in Event Free Rate
param Value
3.36
statistical Method
Z-test

classes

categories
measurements
group Id
OG000
lower Limit
49.23
upper Limit
59.88
value
54.56
group Id
OG001
lower Limit
52.72
upper Limit
63.10
value
57.91

denoms

counts
group Id
OG000
value
359
group Id
OG001
value
360
units
Participants

description

Overall Survival (OS) Event Free Rate at 1 Year.

dispersion Type

95% Confidence Interval

groups

description
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
id
OG000
title
Placebo+Gemcitabine+Carboplatin/Cisplatin
description
Eligible participants received open-label atezolizumab as monotherapy.
id
OG001
title
Atezolizumab Monotherapy

param Type

NUMBER

population Description

The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.

reporting Status

POSTED

time Frame

Year 1

title

OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

type

SECONDARY

unit Of Measure

Percentage

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

Preserved source evidence · Not medical advice