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NCT01658878 · OUTCOME

Serum Concentration Achieved at the End of Dosing Interval (Trough Concentration) (Ctrough)

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer · Source last updated 2025-12-24

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)

What was measured

Ctrough is the lowest observed serum concentration.

Analysis population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.

Groups in this outcome

Cohort 1 Uninfected HCC

Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1/0.3/1/3/10 mg/kg every 2 weeks

Cohort 1 HCV Infected

Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3/1/3 mg/kg every 2 weeks

Cohort 1 HBV Infected

Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1/0.3/1/3 mg/kg every 2 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
Cohort 1 Uninfected HCC21
Cohort 1 HCV Infected9
Cohort 1 HBV Infected15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC21
Cohort 1 HCV Infected9
Cohort 1 HBV Infected15
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC16.52383.95Not reportedNot reportedNot reported
Cohort 1 HCV Infected4.40194.65Not reportedNot reportedNot reported
Cohort 1 HBV Infected2.26412.75Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC6
Cohort 1 HCV Infected5
Cohort 1 HBV Infected3
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC32.48430.86Not reportedNot reportedNot reported
Cohort 1 HCV Infected6.7697.21Not reportedNot reportedNot reported
Cohort 1 HBV Infected8.51473.58Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        383.95
        value
        16.52
      2. group Id
        OG001
        spread
        194.65
        value
        4.40
      3. group Id
        OG002
        spread
        412.75
        value
        2.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        430.86
        value
        32.48
      2. group Id
        OG001
        spread
        97.21
        value
        6.76
      3. group Id
        OG002
        spread
        473.58
        value
        8.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      15
    units
    Participants
description
Ctrough is the lowest observed serum concentration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1/0.3/1/3/10 mg/kg every 2 weeks
    id
    OG000
    title
    Cohort 1 Uninfected HCC
  2. description
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3/1/3 mg/kg every 2 weeks
    id
    OG001
    title
    Cohort 1 HCV Infected
  3. description
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1/0.3/1/3 mg/kg every 2 weeks
    id
    OG002
    title
    Cohort 1 HBV Infected
param Type
GEOMETRIC_MEAN
population Description
All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
reporting Status
POSTED
time Frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)
title
Serum Concentration Achieved at the End of Dosing Interval (Trough Concentration) (Ctrough)
type
SECONDARY
unit Of Measure
ug/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice