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NCT01761266 · ADVERSE EVENTS

Adverse events

A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma · Source last updated 2022-04-05

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 treatment-emergent adverse events were collected from first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 8 years)
Other-event reporting threshold
5%

The safety analysis set included all participants who received at least 1 dose of study drug. All-cause mortality was reported for all participants randomized.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenvatinib

Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

209 / 476469 / 476415 / 478
Sorafenib

Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

149 / 475469 / 475402 / 476

Group identifiers: EG000: Lenvatinib · EG001: Sorafenib

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
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      476
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      475
      num Events
      0
    term
    Disseminated intravascular coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Anaemia vitamin B12 deficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      475
      num Events
      2
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      476
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      475
      num Events
      0
    term
    Cardiopulmonary failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Heart valve stenosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      476
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      475
      num Events
      15
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      476
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      475
      num Events
      2
    term
    Diarrhoea

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      476
      num Events
      82
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      475
      num Events
      54
    term
    Ascites
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      476
      num Events
      95
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      475
      num Events
      62
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      186
      num At Risk
      476
      num Events
      406
    2. group Id
      EG001
      num Affected
      223
      num At Risk
      475
      num Events
      448
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      476
      num Events
      40
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      475
      num Events
      20
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      476
      num Events
      131
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      475
      num Events
      94
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      476
      num Events
      67
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      475
      num Events
      76
    term
    Stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      476
      num Events
      110
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      475
      num Events
      65
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      476
      num Events
      86
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      475
      num Events
      108
    term
    Alanine aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      476
      num Events
      128
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      475
      num Events
      173
    term
    Aspartate aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      476
      num Events
      59
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      475
      num Events
      40
    term
    Blood alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      476
      num Events
      141
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      475
      num Events
      128
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      476
      num Events
      59
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      475
      num Events
      62
    term
    Electrocardiogram QT prolonged
Complete source fields
description
The safety analysis set included all participants who received at least 1 dose of study drug. All-cause mortality was reported for all participants randomized.
event Groups
  1. deaths Num Affected
    415
    deaths Num At Risk
    478
    description
    Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    EG000
    other Num Affected
    469
    other Num At Risk
    476
    serious Num Affected
    209
    serious Num At Risk
    476
    title
    Lenvatinib
  2. deaths Num Affected
    402
    deaths Num At Risk
    476
    description
    Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    EG001
    other Num Affected
    469
    other Num At Risk
    475
    serious Num Affected
    149
    serious Num At Risk
    475
    title
    Sorafenib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      476
      num Events
      82
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      475
      num Events
      54
    term
    Ascites
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      476
      num Events
      95
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      475
      num Events
      62
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      186
      num At Risk
      476
      num Events
      406
    2. group Id
      EG001
      num Affected
      223
      num At Risk
      475
      num Events
      448
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      476
      num Events
      40
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      475
      num Events
      20
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      476
      num Events
      131
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      475
      num Events
      94
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      476
      num Events
      67
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      475
      num Events
      76
    term
    Stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      476
      num Events
      110
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      475
      num Events
      65
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      476
      num Events
      86
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      475
      num Events
      108
    term
    Alanine aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      476
      num Events
      128
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      475
      num Events
      173
    term
    Aspartate aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      476
      num Events
      59
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      475
      num Events
      40
    term
    Blood alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      476
      num Events
      141
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      475
      num Events
      128
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      476
      num Events
      59
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      475
      num Events
      62
    term
    Electrocardiogram QT prolonged
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      476
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      475
      num Events
      0
    term
    Disseminated intravascular coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Anaemia vitamin B12 deficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      475
      num Events
      2
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      476
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      475
      num Events
      0
    term
    Cardiopulmonary failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Heart valve stenosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      476
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      475
      num Events
      1
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      476
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      475
      num Events
      15
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      476
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      475
      num Events
      2
    term
    Diarrhoea
time Frame
All treatment-emergent adverse events were collected from first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 8 years)

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