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NCT01265433 · ADVERSE EVENTS

Adverse events

Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy · Source last updated 2024-10-09

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
Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Galinpepimut-S

Galinpepimut-S + Montanide + GM-CSF

1 / 2017 / 2016 / 20
Control

Montanide + GM-CSF

1 / 2110 / 2120 / 21

Group identifiers: EG000: Galinpepimut-S · EG001: Control

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Lymphopenia

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
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      20
      num Events
      17
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      21
      num Events
      9
    term
    Injection site reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      21
      num Events
      10
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      21
      num Events
      4
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      21
      num Events
      2
    term
    Arthralgias
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Rash, maculopapular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Lymphopenia
Complete source fields
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    20
    description
    Galinpepimut-S + Montanide + GM-CSF
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    20
    serious Num Affected
    1
    serious Num At Risk
    20
    title
    Galinpepimut-S
  2. deaths Num Affected
    20
    deaths Num At Risk
    21
    description
    Montanide + GM-CSF
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    21
    serious Num Affected
    1
    serious Num At Risk
    21
    title
    Control
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      20
      num Events
      17
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      21
      num Events
      9
    term
    Injection site reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      21
      num Events
      10
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      21
      num Events
      4
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      21
      num Events
      2
    term
    Arthralgias
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Rash, maculopapular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Lymphopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Lymphopenia
time Frame
Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016)

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Preserved source evidence · Not medical advice