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NCT01658878 · OUTCOME

Time of Maximum Observed Serum Concentration (Tmax)

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
MEDIAN
Unit
Hour
Interval / dispersion
Full Range
Time frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)

What was measured

Tmax is the time taken to reach the maximum observed serum concentration (Cmax).

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 Infected15

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC23
Cohort 1 HCV Infected10
Cohort 1 HBV Infected15
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC3.00Not reported1.025.2Not reported
Cohort 1 HCV Infected2.98Not reported0.925.2Not reported
Cohort 1 HBV Infected3.00Not reported0.923.9Not reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1 Uninfected HCC8
Cohort 1 HCV Infected6
Cohort 1 HBV Infected3
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC12.75Not reported0.924.3Not reported
Cohort 1 HCV Infected12.28Not reported1.024.5Not reported
Cohort 1 HBV Infected24.13Not reported0.825.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        25.2
        value
        3.00
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        25.2
        value
        2.98
      3. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        23.9
        value
        3.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        24.3
        value
        12.75
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        24.5
        value
        12.28
      3. group Id
        OG002
        lower Limit
        0.8
        upper Limit
        25.7
        value
        24.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      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
      15
    units
    Participants
description
Tmax is the time taken to reach the maximum observed serum concentration (Cmax).
dispersion Type
Full Range
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
MEDIAN
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
Time of Maximum Observed Serum Concentration (Tmax)
type
SECONDARY
unit Of Measure
Hour

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

Preserved source evidence · Not medical advice