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NCT04299048 · OUTCOME

Serum Unbound Trough Concentrations (Ctrough) of PF-06946860

Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. · Source last updated 2023-12-14

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 at Weeks 3, 6, 9 and 12, and at Week 15

What was measured

Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group.

Analysis population: The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported.

Groups in this outcome

PF-06946860 Q3W

During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.

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

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W8

Reported measurements

Week 3

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W4.0411.28*10^19Not reportedNot reportedNot reported
Week 6

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W1690593Not reportedNot reportedNot reported
Week 9

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W610.97.79*10^10Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W4383142Not reportedNot reportedNot reported
Week 15

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W7
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W560.52.15*10^12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.28*10^19
        value
        4.041
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Week 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        593
        value
        1690
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Week 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.79*10^10
        value
        610.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Week 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        142
        value
        4383
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Week 12
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.15*10^12
        value
        560.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Week 15
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
    id
    OG000
    title
    PF-06946860 Q3W
param Type
GEOMETRIC_MEAN
population Description
The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported.
reporting Status
POSTED
time Frame
Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
title
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice