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← Liver Neoplasm

NCT01658878 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

All treated participants

→

primary · POSTED

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.

All treated participants

→

primary · POSTED

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

All treated participants

→

primary · POSTED

Number of participants who died during the study.

All treated participants

→

primary · POSTED

Participants with abnormalities in liver function tests related to potential drug-induced liver injury. Blood samples were collected and analyzed for liver function parameters, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Abnormalities were assessed relative to the upper limit of normal (ULN) for each parameter. Abbreviations: ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal.

All treated participants

→

primary · POSTED

Number of participants with thyroid-related laboratory abnormalities during the study. Blood samples were collected and analyzed for thyroid function markers (FT3, FT4). Abnormalities were assessed against LLN and ULN for each parameter. Abbreviations: FT3 = Free T3; FT4 = Free T4; LLN = Lower Limit of Normal; ULN = Upper Limit of Normal; TSH = Thyroid Stimulating Hormone

All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01658878
trial label
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
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
21
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    source section id
    NCT01658878-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Adverse Events (AEs)
    endpoint definition
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    time origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0001
    source section id
    NCT01658878-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Serious Adverse Events (SAEs)
    endpoint definition
    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.
    time origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0002
    source section id
    NCT01658878-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Adverse Events Leading to Discontinuation
    endpoint definition
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
    time origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0003
    source section id
    NCT01658878-om-0003
    source outcome index
    3
    endpoint
    Number of Participants Who Died
    endpoint definition
    Number of participants who died during the study.
    time origin
    From first dose of study medication until study closure (Up to approximately 144 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0004
    source section id
    NCT01658878-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Laboratory Abnormalities in Specific Liver Tests
    endpoint definition
    Participants with abnormalities in liver function tests related to potential drug-induced liver injury. Blood samples were collected and analyzed for liver function parameters, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Abnormalities were assessed relative to the upper limit of normal (ULN) for each parameter. Abbreviations: ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal.
    time origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0005
    source section id
    NCT01658878-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
    endpoint definition
    Number of participants with thyroid-related laboratory abnormalities during the study. Blood samples were collected and analyzed for thyroid function markers (FT3, FT4). Abnormalities were assessed against LLN and ULN for each parameter. Abbreviations: FT3 = Free T3; FT4 = Free T4; LLN = Lower Limit of Normal; ULN = Upper Limit of Normal; TSH = Thyroid Stimulating Hormone
    time origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1 Uninfected HCC: Treatment 1
    regimen
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 1 Uninfected HCC: Treatment 2
    regimen
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Cohort 1 Uninfected HCC: Treatment 3
    regimen
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Cohort 1 Uninfected HCC: Treatment 4
    regimen
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Cohort 1 Uninfected HCC: Treatment 5
    regimen
    Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Cohort 1 HCV Infected: Treatment 6
    regimen
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG006
    arm label
    Cohort 1 HCV Infected: Treatment 7
    regimen
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG007
    arm label
    Cohort 1 HCV Infected: Treatment 8
    regimen
    Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG007
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG008
    arm label
    Cohort 1 HBV Infected: Treatment 9
    regimen
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG008
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG009
    arm label
    Cohort 1 HBV Infected: Treatment 10
    regimen
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG009
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG010
    arm label
    Cohort 1 HBV Infected: Treatment 11
    regimen
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG010
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    outcome key
    om-0000
    arm key
    OG011
    arm label
    Cohort 1 HBV Infected: Treatment 12
    regimen
    Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01658878-om-0000#groups/OG011
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG000
    source section id
    NCT01658878-ae
    event group key
    EG000
    event group label
    Cohort 1 Uninfected HCC: Treatment 1
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG001
    source section id
    NCT01658878-ae
    event group key
    EG001
    event group label
    Cohort 1 Uninfected HCC: Treatment 2
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG002
    source section id
    NCT01658878-ae
    event group key
    EG002
    event group label
    Cohort 1 Uninfected HCC: Treatment 3
    serious affected
    2
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG003
    source section id
    NCT01658878-ae
    event group key
    EG003
    event group label
    Cohort 1 Uninfected HCC: Treatment 4
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG004
    source section id
    NCT01658878-ae
    event group key
    EG004
    event group label
    Cohort 1 Uninfected HCC: Treatment 5
    serious affected
    8
    serious at risk
    13
    other affected
    13
    other at risk
    13
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG005
    source section id
    NCT01658878-ae
    event group key
    EG005
    event group label
    Cohort 1 HCV Infected: Treatment 6
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG006
    source section id
    NCT01658878-ae
    event group key
    EG006
    event group label
    Cohort 1 HCV Infected: Treatment 7
    serious affected
    3
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG007
    source section id
    NCT01658878-ae
    event group key
    EG007
    event group label
    Cohort 1 HCV Infected: Treatment 8
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG008
    source section id
    NCT01658878-ae
    event group key
    EG008
    event group label
    Cohort 1 HBV Infected: Treatment 9
    serious affected
    5
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG009
    source section id
    NCT01658878-ae
    event group key
    EG009
    event group label
    Cohort 1 HBV Infected: Treatment 10
    serious affected
    3
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG010
    source section id
    NCT01658878-ae
    event group key
    EG010
    event group label
    Cohort 1 HBV Infected: Treatment 11
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT01658878
    harm key
    EG011
    source section id
    NCT01658878-ae
    event group key
    EG011
    event group label
    Cohort 1 HBV Infected: Treatment 12
    serious affected
    3
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
    event definition
    The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice