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NCT01018979 · OUTCOME

Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-05-11

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

Measure
MEAN
Unit
hr
Interval / dispersion
Standard Deviation
Time frame
36 hrs after infusion

What was measured

Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

Analysis population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.

Groups in this outcome

TG-0054 (2.24 mg/kg)

TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

TG-0054 (3.14 mg/kg)

TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

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

Analysis denominator · Participants

GroupSource count
TG-0054 (2.24 mg/kg)6
TG-0054 (3.14 mg/kg)6

Reported measurements

Source class 1
Values in hr · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
TG-0054 (2.24 mg/kg)4.650.4Not reportedNot reportedNot reported
TG-0054 (3.14 mg/kg)4.280.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.4
        value
        4.65
      2. group Id
        OG001
        spread
        0.6
        value
        4.28
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
dispersion Type
Standard Deviation
groups
  1. description
    TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    OG000
    title
    TG-0054 (2.24 mg/kg)
  2. description
    TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    OG001
    title
    TG-0054 (3.14 mg/kg)
param Type
MEAN
population Description
According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
reporting Status
POSTED
time Frame
36 hrs after infusion
title
Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
type
SECONDARY
unit Of Measure
hr

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

Preserved source evidence · Not medical advice