NCT02108652 · OUTCOME

Maximum Serum Concentration (Cmax) of Atezolizumab

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2) · Source last updated 2024-03-28

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

Measure: MEAN
Unit: microgram(s)/milliliter (mcg/mL)
Interval / dispersion: Standard Deviation
Time frame: Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)

Analysis population: Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.

Groups in this outcome

Cohort 2: Participants With Second-line or Beyond Treatments

Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.

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
Cohort 2: Participants With Second-line or Beyond Treatments	300

Reported measurements

Source class 1

Values in microgram(s)/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 2: Participants With Second-line or Beyond Treatments	364	120	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
120
value
364

denoms

counts
group Id
OG000
value
300
units
Participants

dispersion Type

Standard Deviation

groups

description
Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
id
OG000
title
Cohort 2: Participants With Second-line or Beyond Treatments

param Type

MEAN

population Description

Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.

reporting Status

POSTED

time Frame

Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)

title

Maximum Serum Concentration (Cmax) of Atezolizumab

type

SECONDARY

unit Of Measure

microgram(s)/milliliter (mcg/mL)

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

Preserved source evidence · Not medical advice