Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01658878 · OUTCOME

Serum Concentration Achieved at the End of the Infusion (Ceoinf)

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

Serum Concentration Achieved at the End of the Infusion (Ceoinf) refers to the amount of drug present in the blood (serum) immediately after the completion of an infusion. It represents the concentration measured at the exact time the infusion ends, before any significant elimination or distribution occurs.

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 HCC23
Cohort 1 HCV Infected10
Cohort 1 HBV Infected14

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC23
Cohort 1 HCV Infected10
Cohort 1 HBV Infected14
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC49.88315.39Not reportedNot reportedNot reported
Cohort 1 HCV Infected17.07123.95Not reportedNot reportedNot reported
Cohort 1 HBV Infected6.99254.53Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC8
Cohort 1 HCV Infected5
Cohort 1 HBV Infected5
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC84.36371.92Not reportedNot reportedNot reported
Cohort 1 HCV Infected25.53147.16Not reportedNot reportedNot reported
Cohort 1 HBV Infected11.80353.06Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        315.39
        value
        49.88
      2. group Id
        OG001
        spread
        123.95
        value
        17.07
      3. group Id
        OG002
        spread
        254.53
        value
        6.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        371.92
        value
        84.36
      2. group Id
        OG001
        spread
        147.16
        value
        25.53
      3. group Id
        OG002
        spread
        353.06
        value
        11.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Serum Concentration Achieved at the End of the Infusion (Ceoinf) refers to the amount of drug present in the blood (serum) immediately after the completion of an infusion. It represents the concentration measured at the exact time the infusion ends, before any significant elimination or distribution occurs.
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 the Infusion (Ceoinf)
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice