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NCT01380145 · ADVERSE EVENTS

Adverse events

MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation · Source last updated 2022-10-25

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
All AEs occurring between the date of enrollment and the off-study date (i.e., for up to 14 months) were documented, regardless of the causal relationship to study drug. AEs occurring or worsening after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
Other-event reporting threshold
0%

AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Safety Analysis Set

Includes all subjects who received at least 1 immunization with study drug.

4 / 1313 / 13Not reported / Not reported

Group identifiers: EG000: Safety Analysis Set

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
    notes
    Grade 2, unresolved; represents a potential immune-mediated disease (pIMD)
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Psoriasis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, unresolved
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Connective tissue disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, resolved
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, resolved
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, resolved
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 1, resolved
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Injection site reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, resolved
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Myalgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, resolved
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, resolved
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Pulmonary oedema

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
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      13
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      13
    term
    Decreased appetite
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Insomnia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    term
    Febrile neutropenia
Complete source fields
description
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
event Groups
  1. description
    Includes all subjects who received at least 1 immunization with study drug.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Safety Analysis Set
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      13
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      13
    term
    Decreased appetite
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Insomnia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    term
    Febrile neutropenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, unresolved; represents a potential immune-mediated disease (pIMD)
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Psoriasis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, unresolved
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Connective tissue disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, resolved
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, resolved
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, resolved
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 1, resolved
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Injection site reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, resolved
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Myalgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, resolved
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, resolved
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (13.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Pulmonary oedema
time Frame
All AEs occurring between the date of enrollment and the off-study date (i.e., for up to 14 months) were documented, regardless of the causal relationship to study drug. AEs occurring or worsening after the first dose of study drug were considered treatment emergent (i.e., TEAEs).

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