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NCT02064387 · OUTCOME

Ctrough of GSK2857916 Following IV Dose in Participants With NHL-Part 2

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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

Measure
MEAN
Unit
Nanograms per milliliter
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 3)

What was measured

Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.

Analysis population: Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (NHL)

Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).

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

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5

Reported measurements

Cycle 1 Day 1, n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0.00.00Not reportedNot reportedNot reported
Cycle 2 Day 1, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)3761.82225.57Not reportedNot reportedNot reported
Cycle 3 Day 1, n=1

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)1
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)8401.0NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Cycle 1 Day 1, n=5
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2225.57
        value
        3761.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2 Day 1, n=4
  3. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        8401.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 3 Day 1, n=1
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
param Type
MEAN
population Description
Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
reporting Status
POSTED
time Frame
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 3)
title
Ctrough of GSK2857916 Following IV Dose in Participants With NHL-Part 2
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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

Preserved source evidence · Not medical advice