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NCT02718417 · OUTCOME

Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)

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
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2

What was measured

Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.

Analysis population: Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. 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.

PK: Chemotherapy + Avelumab Followed by Avelumab

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab 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).

PK: Chemotherapy Followed by Observation

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.

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 Avelumab11
PK: Chemotherapy + Avelumab Followed by Avelumab7
PK: Chemotherapy Followed by Observation13

Reported measurements

Total Carboplatin
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PK: Chemotherapy Followed by Avelumab2358034Not reportedNot reportedNot reported
PK: Chemotherapy + Avelumab Followed by Avelumab1835044Not reportedNot reportedNot reported
PK: Chemotherapy Followed by Observation1899031Not reportedNot reportedNot reported
Free Carboplatin
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PK: Chemotherapy Followed by Avelumab2174039Not reportedNot reportedNot reported
PK: Chemotherapy + Avelumab Followed by Avelumab1535065Not reportedNot reportedNot reported
PK: Chemotherapy Followed by Observation1709033Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        34
        value
        23580
      2. group Id
        OG001
        spread
        44
        value
        18350
      3. group Id
        OG002
        spread
        31
        value
        18990
    title
    Total Carboplatin
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39
        value
        21740
      2. group Id
        OG001
        spread
        65
        value
        15350
      3. group Id
        OG002
        spread
        33
        value
        17090
    title
    Free Carboplatin
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      13
    units
    Participants
description
Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL.
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
  2. description
    In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab 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
    OG001
    title
    PK: Chemotherapy + Avelumab Followed by Avelumab
  3. description
    In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
    id
    OG002
    title
    PK: Chemotherapy Followed by Observation
param Type
GEOMETRIC_MEAN
population Description
Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
reporting Status
POSTED
time Frame
Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
title
Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice