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NCT03848182 · ADVERSE EVENTS

Adverse events

Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer · Source last updated 2024-04-18

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
Up to 1 month following Gemcitabine administration, for a total of up to 2 months
Other-event reporting threshold
0%

Adverse events were reported and coded using the Modified NCI Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gemcitabine With TT Vaccine Booster

Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8

2 / 1010 / 100 / 10

Group identifiers: EG000: Gemcitabine With TT Vaccine Booster

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
    notes
    Verbatim Term: Perforated Gall Bladder
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Gallbladder Perforation
  2. 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
      10
      num Events
      1
    term
    Duodenal Hemorrhage

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
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Diarrhea
  3. 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
      10
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Dizziness
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Rash maculo-papular
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Terms: Abdominal Pain, Intermittent Abdominal Pain, Abdominal Discomfort
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Terms: Dyspnea, Shortness of Breath
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Dyspnea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Terms: Chest Pain, Occasional Chest Pain
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Chest Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Bilateral Lower Extremity Edema
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Edema Limbs
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Weakness
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    term
    Generalized Muscle Weakness
Complete source fields
description
Adverse events were reported and coded using the Modified NCI Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Gemcitabine With TT Vaccine Booster
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Diarrhea
  3. 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
      10
    term
    Nausea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Dizziness
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Rash maculo-papular
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Terms: Abdominal Pain, Intermittent Abdominal Pain, Abdominal Discomfort
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Terms: Dyspnea, Shortness of Breath
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Dyspnea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Terms: Chest Pain, Occasional Chest Pain
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Chest Pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Bilateral Lower Extremity Edema
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Edema Limbs
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Weakness
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    term
    Generalized Muscle Weakness
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Verbatim Term: Perforated Gall Bladder
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Gallbladder Perforation
  2. 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
      10
      num Events
      1
    term
    Duodenal Hemorrhage
time Frame
Up to 1 month following Gemcitabine administration, for a total of up to 2 months

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

Preserved source evidence · Not medical advice