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NCT02108652 · OUTCOME

Minimum Serum Concentration (Cmin) 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
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)

Analysis population: Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. "n" = participants who were evaluable at specified timepoint.

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

GroupSource count
Cohort 2: Participants With Second-line or Beyond Treatments303

Reported measurements

Pre-dose Cycle 1 (n=303)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 2: Participants With Second-line or Beyond Treatments0.02520.429Not reportedNot reportedNot reported
Pre-dose Cycle 2 (n=269)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 2: Participants With Second-line or Beyond Treatments74.229.9Not reportedNot reportedNot reported
Pre-dose Cycle 3 (n=146)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 2: Participants With Second-line or Beyond Treatments120.059.5Not reportedNot reportedNot reported
Pre-dose Cycle 4 (n=186)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 2: Participants With Second-line or Beyond Treatments147.077.7Not reportedNot reportedNot reported
Pre-dose Cycle 8 (n=108)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 2: Participants With Second-line or Beyond Treatments188.076.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.429
        value
        0.0252
    title
    Pre-dose Cycle 1 (n=303)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.9
        value
        74.2
    title
    Pre-dose Cycle 2 (n=269)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.5
        value
        120.0
    title
    Pre-dose Cycle 3 (n=146)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        77.7
        value
        147.0
    title
    Pre-dose Cycle 4 (n=186)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.1
        value
        188.0
    title
    Pre-dose Cycle 8 (n=108)
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. 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 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. "n" = participants who were evaluable at specified timepoint.
reporting Status
POSTED
time Frame
Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)
title
Minimum Serum Concentration (Cmin) of Atezolizumab
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice