Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02040142 · ADVERSE EVENTS

Adverse events

HIPEC for Peritoneal Carcinomatosis · Source last updated 2024-10-24

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
Assessed throughout enrollment following the initiation of study treatment, up to 5 years
Other-event reporting threshold
0%

Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HIPEC + Mitomycin C

HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C

34 / 5150 / 5117 / 51

Group identifiers: EG000: HIPEC + Mitomycin C

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    term
    Acute Kidney Injury
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: AST Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      51
    term
    Aspartate Aminotransferase (AST) Increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: ALT Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      51
    term
    Alanine Aminotransferase (ALT) Increased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Creatinine Increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Chronic Kidney Disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    term
    Dyspnea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    term
    Fever
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Hemoglobin Decreased
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      51
    term
    Anemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Hypoalbuminemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      51
    term
    Hypocalcemia

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
    notes
    Verbatim Term: AST Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      51
    term
    Aspartate Aminotransferase (AST) Increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: ALT Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      51
    term
    Alanine Aminotransferase (ALT) Increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      51
    term
    Hyperglycemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      51
    term
    Hypocalcemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      51
    term
    Hypertension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      51
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Neutropenia
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
    term
    Febrile Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Hemoglobin Decrease
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      51
    term
    Anemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      51
    term
    Hypoalbuminemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Lymphocyte Decrease
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      51
    term
    Lymphocyte Count Decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: White Blood Cell Count Decrease
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      51
    term
    White Blood Cell Decreased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Blood Bilirubin
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      51
    term
    Blood Bilirubin Increased
Complete source fields
description
Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    51
    description
    HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
    id
    EG000
    other Num Affected
    50
    other Num At Risk
    51
    serious Num Affected
    34
    serious Num At Risk
    51
    title
    HIPEC + Mitomycin C
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: AST Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      51
    term
    Aspartate Aminotransferase (AST) Increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: ALT Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      51
    term
    Alanine Aminotransferase (ALT) Increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      51
    term
    Hyperglycemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      51
    term
    Hypocalcemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      51
    term
    Hypertension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      51
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Neutropenia
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
    term
    Febrile Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Hemoglobin Decrease
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      51
    term
    Anemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      51
    term
    Hypoalbuminemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Lymphocyte Decrease
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      51
    term
    Lymphocyte Count Decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: White Blood Cell Count Decrease
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      51
    term
    White Blood Cell Decreased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Blood Bilirubin
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      51
    term
    Blood Bilirubin Increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    term
    Acute Kidney Injury
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    AEs as identified by CTCAE Version 4.0 were coded to their appropriate System Organ Class (SOC)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: AST Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      51
    term
    Aspartate Aminotransferase (AST) Increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: ALT Increase
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      51
    term
    Alanine Aminotransferase (ALT) Increased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Creatinine Increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Chronic Kidney Disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      51
    term
    Dyspnea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    term
    Fever
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Hemoglobin Decreased
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      51
    term
    Anemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Hypoalbuminemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      51
    term
    Hypocalcemia
time Frame
Assessed throughout enrollment following the initiation of study treatment, up to 5 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice