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NCT00004547 · ADVERSE EVENTS

Adverse events

Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy · Source last updated 2015-11-18

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
Not reported
Other-event reporting threshold
0%

Adverse Events: 188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P.Meso + 48 L.Grade + 57 Adeno. = 188).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Mesothelioma, Low Grade, and Adenocarcinoma

Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.

71 / 1882 / 188Not reported / Not reported

Group identifiers: EG000: Mesothelioma, Low Grade, and Adenocarcinoma

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
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    ascites
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    cholecystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    colon perforation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    Deep venous thrombosis (DVT)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Enterocutaneous fistula
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    Gastric perforation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    Gastrointestinal (GI) perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Hallucinations/post operative (op) psychosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Ileus

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
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Sinus ventricular tachycardia (SVT)
Complete source fields
description
Adverse Events: 188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P.Meso + 48 L.Grade + 57 Adeno. = 188).
event Groups
  1. description
    Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    188
    serious Num Affected
    71
    serious Num At Risk
    188
    title
    Mesothelioma, Low Grade, and Adenocarcinoma
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Sinus ventricular tachycardia (SVT)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    ascites
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    cholecystitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    colon perforation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    Deep venous thrombosis (DVT)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Enterocutaneous fistula
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    Gastric perforation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      188
      num Events
      1
    term
    Gastrointestinal (GI) perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Hallucinations/post operative (op) psychosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC2.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      188
      num Events
      2
    term
    Ileus

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Preserved source evidence · Not medical advice