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NCT01018979 · OUTCOME

Time at Which Maximum Plasma Concentration is Observed (Tmax) 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)0.250Not reportedNot reportedNot reported
TG-0054 (3.14 mg/kg)0.250Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        0.25
      2. group Id
        OG001
        spread
        0
        value
        0.25
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
Time at Which Maximum Plasma Concentration is Observed (Tmax) 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