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NCT02576509 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2025-02-17

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All cause mortality was collected from randomization up to last survival follow up (approximately up to 98 months). Serious and non-serious adverse events were collected from first dose till 100 days after last dose of study therapy (up to approximately 95 months).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Nivolumab 240 mg

Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity

216 / 367339 / 367321 / 371
Sorafenib 400 mg

Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity

216 / 363351 / 363335 / 372

Group identifiers: EG000: Nivolumab 240 mg · EG001: Sorafenib 400 mg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      363
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Aortic valve incompetence
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Cardiac failure acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Coronary artery disease

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      363
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      363
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      363
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      363
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      363
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      363
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      363
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      191
      num At Risk
      363
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      363
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      363
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      363
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      363
    term
    Asthenia
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    321
    deaths Num At Risk
    371
    description
    Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
    id
    EG000
    other Num Affected
    339
    other Num At Risk
    367
    serious Num Affected
    216
    serious Num At Risk
    367
    title
    Nivolumab 240 mg
  2. deaths Num Affected
    335
    deaths Num At Risk
    372
    description
    Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
    id
    EG001
    other Num Affected
    351
    other Num At Risk
    363
    serious Num Affected
    216
    serious Num At Risk
    363
    title
    Sorafenib 400 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      363
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      363
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      363
    term
    Abdominal distension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      363
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      363
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      363
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      363
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      191
      num At Risk
      363
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      363
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      363
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      363
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      363
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      363
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Aortic valve incompetence
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      363
    term
    Cardiac failure acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      367
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      363
    term
    Coronary artery disease
time Frame
All cause mortality was collected from randomization up to last survival follow up (approximately up to 98 months). Serious and non-serious adverse events were collected from first dose till 100 days after last dose of study therapy (up to approximately 95 months).

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