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NCT03689192 · ADVERSE EVENTS

Adverse events

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors · Source last updated 2023-02-28

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
Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ARG1-18,19,20 Peptide Vaccine

One ARG1-vaccine every third week for 45 weeks. ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide

3 / 1010 / 109 / 10

Group identifiers: EG000: ARG1-18,19,20 Peptide Vaccine

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
    not related to study drug
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Ascites
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    not related to study drug
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    not related to study drug
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Facial paralysis

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
    term
    Fatique
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Xerostomia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    Granuloma at injection site
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Mucositis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Rash
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    10
    description
    One ARG1-vaccine every third week for 45 weeks. ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    ARG1-18,19,20 Peptide Vaccine
frequency Threshold
1
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
    term
    Fatique
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Xerostomia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    Granuloma at injection site
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Mucositis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    Rash
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    not related to study drug
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Ascites
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    not related to study drug
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    not related to study drug
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    Facial paralysis
time Frame
Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)

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Preserved source evidence · Not medical advice