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NCT01658878 · OUTCOME

Number of Participants With Serious Adverse Events (SAEs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)

What was measured

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Analysis population: All treated participants

Groups in this outcome

Cohort 1 Uninfected HCC: Treatment 1

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

Cohort 1 Uninfected HCC: Treatment 2

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

Cohort 1 Uninfected HCC: Treatment 3

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

Cohort 1 Uninfected HCC: Treatment 4

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

Cohort 1 Uninfected HCC: Treatment 5

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

Cohort 1 HCV Infected: Treatment 6

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

Cohort 1 HCV Infected: Treatment 7

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

Cohort 1 HCV Infected: Treatment 8

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

Cohort 1 HBV Infected: Treatment 9

Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks

Cohort 1 HBV Infected: Treatment 10

Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks

Cohort 1 HBV Infected: Treatment 11

Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks

Cohort 1 HBV Infected: Treatment 12

Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks

Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1

Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks

Cohort 2 Uninfected Sorafenib Progressors: Treatment 2

Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks

Cohort 2 HCV Infected: Treatment 3

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

Cohort 2 HBV Infected: Treatment 4

Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks

Cohort 3: Treatment 1

Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks

Cohort 3: Treatment 2

Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day

Cohort 4: Treatment 1

Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks

Cohort 4: Treatment 2

Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks

Cohort 4: Treatment 3

Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks

Cohort 5: Treatment 1

Participants received nivolumab 240 mg every 2 weeks

Cohort 6: Treatment 1

Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily

Cohort 6: Treatment 2

Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily

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 HCC: Treatment 11
Cohort 1 Uninfected HCC: Treatment 23
Cohort 1 Uninfected HCC: Treatment 33
Cohort 1 Uninfected HCC: Treatment 43
Cohort 1 Uninfected HCC: Treatment 513
Cohort 1 HCV Infected: Treatment 63
Cohort 1 HCV Infected: Treatment 74
Cohort 1 HCV Infected: Treatment 83
Cohort 1 HBV Infected: Treatment 95
Cohort 1 HBV Infected: Treatment 103
Cohort 1 HBV Infected: Treatment 113
Cohort 1 HBV Infected: Treatment 124
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 156
Cohort 2 Uninfected Sorafenib Progressors: Treatment 257
Cohort 2 HCV Infected: Treatment 350
Cohort 2 HBV Infected: Treatment 451
Cohort 3: Treatment 160
Cohort 3: Treatment 262
Cohort 4: Treatment 149
Cohort 4: Treatment 249
Cohort 4: Treatment 348
Cohort 5: Treatment 149
Cohort 6: Treatment 136
Cohort 6: Treatment 235

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Uninfected HCC: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort 1 Uninfected HCC: Treatment 21Not reportedNot reportedNot reportedNot reported
Cohort 1 Uninfected HCC: Treatment 32Not reportedNot reportedNot reportedNot reported
Cohort 1 Uninfected HCC: Treatment 40Not reportedNot reportedNot reportedNot reported
Cohort 1 Uninfected HCC: Treatment 55Not reportedNot reportedNot reportedNot reported
Cohort 1 HCV Infected: Treatment 60Not reportedNot reportedNot reportedNot reported
Cohort 1 HCV Infected: Treatment 73Not reportedNot reportedNot reportedNot reported
Cohort 1 HCV Infected: Treatment 81Not reportedNot reportedNot reportedNot reported
Cohort 1 HBV Infected: Treatment 95Not reportedNot reportedNot reportedNot reported
Cohort 1 HBV Infected: Treatment 103Not reportedNot reportedNot reportedNot reported
Cohort 1 HBV Infected: Treatment 110Not reportedNot reportedNot reportedNot reported
Cohort 1 HBV Infected: Treatment 122Not reportedNot reportedNot reportedNot reported
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 134Not reportedNot reportedNot reportedNot reported
Cohort 2 Uninfected Sorafenib Progressors: Treatment 228Not reportedNot reportedNot reportedNot reported
Cohort 2 HCV Infected: Treatment 329Not reportedNot reportedNot reportedNot reported
Cohort 2 HBV Infected: Treatment 421Not reportedNot reportedNot reportedNot reported
Cohort 3: Treatment 127Not reportedNot reportedNot reportedNot reported
Cohort 3: Treatment 225Not reportedNot reportedNot reportedNot reported
Cohort 4: Treatment 130Not reportedNot reportedNot reportedNot reported
Cohort 4: Treatment 227Not reportedNot reportedNot reportedNot reported
Cohort 4: Treatment 329Not reportedNot reportedNot reportedNot reported
Cohort 5: Treatment 131Not reportedNot reportedNot reportedNot reported
Cohort 6: Treatment 117Not reportedNot reportedNot reportedNot reported
Cohort 6: Treatment 221Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      13
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      5
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      4
    units
    Participants
description
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
groups
  1. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
    id
    OG000
    title
    Cohort 1 Uninfected HCC: Treatment 1
  2. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
    id
    OG001
    title
    Cohort 1 Uninfected HCC: Treatment 2
  3. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
    id
    OG002
    title
    Cohort 1 Uninfected HCC: Treatment 3
  4. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
    id
    OG003
    title
    Cohort 1 Uninfected HCC: Treatment 4
  5. description
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
    id
    OG004
    title
    Cohort 1 Uninfected HCC: Treatment 5
  6. description
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
    id
    OG005
    title
    Cohort 1 HCV Infected: Treatment 6
  7. description
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
    id
    OG006
    title
    Cohort 1 HCV Infected: Treatment 7
  8. description
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
    id
    OG007
    title
    Cohort 1 HCV Infected: Treatment 8
  9. description
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
    id
    OG008
    title
    Cohort 1 HBV Infected: Treatment 9
  10. description
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
    id
    OG009
    title
    Cohort 1 HBV Infected: Treatment 10
  11. description
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
    id
    OG010
    title
    Cohort 1 HBV Infected: Treatment 11
  12. description
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
    id
    OG011
    title
    Cohort 1 HBV Infected: Treatment 12
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants
reporting Status
POSTED
time Frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
title
Number of Participants With Serious Adverse Events (SAEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice