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NCT01536145 · OUTCOME

Human Anti-human Antibody (HAHA) Response to CP-751,871

CP-751,871 Treatment For Patients With Multiple Myeloma · Source last updated 2013-03-15

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

Measure
NUMBER
Unit
Not reported
Interval / dispersion
Not reported
Time frame
30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg

Analysis population: All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.

Groups in this outcome

CP-751,871 0.025-20 mg/kg

CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

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

Analysis denominator · Participants

GroupSource count
CP-751,871 0.025-20 mg/kg28

Reported measurements

Source class 1
Values in Not reported · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CP-751,871 0.025-20 mg/kgNANot reportedNot reportedNot reportedNone of the analyzed samples were positive for anti-CP-751,871 antibodies, as suggested by a titer measurement of less than 3.32.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        None of the analyzed samples were positive for anti-CP-751,871 antibodies, as suggested by a titer measurement of less than 3.32.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
groups
  1. description
    CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
    id
    OG000
    title
    CP-751,871 0.025-20 mg/kg
param Type
NUMBER
population Description
All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.
reporting Status
POSTED
time Frame
30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg
title
Human Anti-human Antibody (HAHA) Response to CP-751,871
type
SECONDARY

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

Preserved source evidence · Not medical advice