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NCT01730937 · ADVERSE EVENTS

Adverse events

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer · Source last updated 2026-01-28

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
From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
Other-event reporting threshold
5%

All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.

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

400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

20 / 8888 / 8880 / 92
SBRT Followed by Sorafenib

27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

19 / 8383 / 8373 / 85

Group identifiers: EG000: Sorafenib Alone · EG001: SBRT Followed by 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Blood and lymphatic system disorders - Other, specify
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Duodenal perforation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Duodenal ulcer
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Gastrointestinal disorders - Other, specify
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Gastrointestinal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Lower gastrointestinal hemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Pancreatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Upper gastrointestinal hemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Death NOS

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      83
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Abdominal distension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      83
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
    term
    Bloating
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      83
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      83
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      83
    term
    Gastrointestinal disorders - Other, specify
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
    term
    Gastrointestinal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      83
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      83
    term
    Vomiting
Complete source fields
description
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
event Groups
  1. deaths Num Affected
    80
    deaths Num At Risk
    92
    description
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    88
    other Num At Risk
    88
    serious Num Affected
    20
    serious Num At Risk
    88
    title
    Sorafenib Alone
  2. deaths Num Affected
    73
    deaths Num At Risk
    85
    description
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    83
    other Num At Risk
    83
    serious Num Affected
    19
    serious Num At Risk
    83
    title
    SBRT Followed by Sorafenib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      83
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Abdominal distension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      83
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      83
    term
    Bloating
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      83
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      83
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      83
    term
    Gastrointestinal disorders - Other, specify
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      83
    term
    Gastrointestinal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      83
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      83
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      83
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Blood and lymphatic system disorders - Other, specify
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Duodenal perforation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Duodenal ulcer
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    term
    Gastrointestinal disorders - Other, specify
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Gastrointestinal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Lower gastrointestinal hemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Pancreatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    term
    Upper gastrointestinal hemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    term
    Death NOS
time Frame
From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

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