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NCT01794520 · OUTCOME

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-04-10

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose

What was measured

Tmax is the the time at which the maximum plasma concentration (Cmax) is observed.

Analysis population: Phase 1 dose escalation and safety expansion participants with available data

Groups in this outcome

300 mg Venetoclax

Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day

600 mg Venetoclax

Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day

900 mg Venetoclax

Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day

1200 mg Venetoclax

Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day

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

Analysis denominator · Participants

GroupSource count
300 mg Venetoclax6
600 mg Venetoclax5
900 mg Venetoclax4
1200 mg Venetoclax12

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
300 mg Venetoclax5.0Not reported2.08.0Not reported
600 mg Venetoclax8.0Not reported2.78.0Not reported
900 mg Venetoclax6.0Not reported4.08.0Not reported
1200 mg Venetoclax6.1Not reported4.08.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        8.0
        value
        5.0
      2. group Id
        OG001
        lower Limit
        2.7
        upper Limit
        8.0
        value
        8.0
      3. group Id
        OG002
        lower Limit
        4.0
        upper Limit
        8.0
        value
        6.0
      4. group Id
        OG003
        lower Limit
        4.0
        upper Limit
        8.0
        value
        6.1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      12
    units
    Participants
description
Tmax is the the time at which the maximum plasma concentration (Cmax) is observed.
dispersion Type
Full Range
groups
  1. description
    Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
    id
    OG000
    title
    300 mg Venetoclax
  2. description
    Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
    id
    OG001
    title
    600 mg Venetoclax
  3. description
    Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
    id
    OG002
    title
    900 mg Venetoclax
  4. description
    Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
    id
    OG003
    title
    1200 mg Venetoclax
param Type
MEDIAN
population Description
Phase 1 dose escalation and safety expansion participants with available data
reporting Status
POSTED
time Frame
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose
title
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
type
PRIMARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice