Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01794520 · OUTCOME

Phase 1: Maximum Observed Plasma Concentration (Cmax) 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
MEAN
Unit
µg/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose

What was measured

Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

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 µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
300 mg Venetoclax0.8970.593Not reportedNot reportedNot reported
600 mg Venetoclax2.561.77Not reportedNot reportedNot reported
900 mg Venetoclax1.851.30Not reportedNot reportedNot reported
1200 mg Venetoclax4.161.52Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.593
        value
        0.897
      2. group Id
        OG001
        spread
        1.77
        value
        2.56
      3. group Id
        OG002
        spread
        1.30
        value
        1.85
      4. group Id
        OG003
        spread
        1.52
        value
        4.16
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
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
dispersion Type
Standard Deviation
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
MEAN
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: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
type
PRIMARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice