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NCT04083378 · ADVERSE EVENTS

Adverse events

Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study · Source last updated 2026-03-23

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
Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Other-event reporting threshold
0%

Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.

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

Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors

39 / 7418 / 7426 / 74
Control

Morfeus software was not used during the percutaneous ablation of liver tumors

12 / 263 / 266 / 26

Group identifiers: EG000: Experimental · EG001: Control

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      74
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
      num Events
      4
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Acute kidney injury
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Allergic reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Back pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Colonic obstruction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Breast infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Bleeding
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      74
      num Events
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      26
      num Events
      6
    term
    Death
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Dehydration

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Back pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Chest pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Infection (COVID-19)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Fever
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Hematuria
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Memory impairment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Hematoma
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Rectal pain
Complete source fields
description
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    74
    description
    Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    74
    serious Num Affected
    39
    serious Num At Risk
    74
    title
    Experimental
  2. deaths Num Affected
    6
    deaths Num At Risk
    26
    description
    Morfeus software was not used during the percutaneous ablation of liver tumors
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    26
    serious Num Affected
    12
    serious Num At Risk
    26
    title
    Control
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      74
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Back pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Chest pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Infection (COVID-19)
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Fever
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Hematuria
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Memory impairment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Hematoma
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Rectal pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      74
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
      num Events
      4
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Acute kidney injury
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Allergic reaction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Back pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Colonic obstruction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Breast infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Bleeding
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      74
      num Events
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      26
      num Events
      6
    term
    Death
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      74
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Dehydration
time Frame
Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.

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