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NCT02718417 · OUTCOME

Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) · Source last updated 2020-07-14

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

Measure
GEOMETRIC_MEAN
Unit
mcg/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose (0 hour) on Day 1 of Cycle 2

What was measured

Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).

Analysis population: Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.

Groups in this outcome

PK: Chemotherapy Followed by Avelumab

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PK: Chemotherapy Followed by Avelumab209

Reported measurements

Source class 1
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PK: Chemotherapy Followed by Avelumab29.1857Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        57
        value
        29.18
denoms
  1. counts
    1. group Id
      OG000
      value
      209
    units
    Participants
description
Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
    id
    OG000
    title
    PK: Chemotherapy Followed by Avelumab
param Type
GEOMETRIC_MEAN
population Description
Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
reporting Status
POSTED
time Frame
Pre-dose (0 hour) on Day 1 of Cycle 2
title
Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice