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NCT03439085 · ADVERSE EVENTS

Adverse events

DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers · Source last updated 2024-07-09

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 the first dose through 30 days after the last dose of study medication, up to 2 years
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Group

Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.

1 / 2121 / 212 / 21

Group identifiers: EG000: Treatment Group

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
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Lipase increased

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      21
    term
    Alanine aminotransferase - increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
    term
    Alkaline phosphatase - increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Arthralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
    term
    Aspartate aminotransferase - increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    term
    CPK increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Cholecystitis
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    21
    description
    Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    1
    serious Num At Risk
    21
    title
    Treatment Group
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      21
    term
    Alanine aminotransferase - increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
    term
    Alkaline phosphatase - increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Arthralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      21
    term
    Aspartate aminotransferase - increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
    term
    CPK increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Cholecystitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.3)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    term
    Lipase increased
time Frame
From the first dose through 30 days after the last dose of study medication, up to 2 years

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Preserved source evidence · Not medical advice