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NCT01353222 · ADVERSE EVENTS

Adverse events

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma · Source last updated 2017-05-25

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
Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later.
Other-event reporting threshold
5%

Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DN24-02

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

20 / 6764 / 6730 / 67
Standard of Care

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

17 / 7252 / 7230 / 72

Group identifiers: EG000: DN24-02 · EG001: Standard of Care

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
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    THROMBOCYTOPENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    ATRIAL FIBRILLATION
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    CARDIAC FAILURE ACUTE
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    CARDIOGENIC SHOCK
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      72
      num Events
      5
    term
    SMALL INTESTINAL OBSTRUCTION
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    ABDOMINAL PAIN
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    INTESTINAL OBSTRUCTION
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    NAUSEA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    VOMITING
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    DUODENAL ULCER
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    GASTROINTESTINAL NECROSIS

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      6
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      67
      num Events
      15
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      72
      num Events
      10
    term
    CONSTIPATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      67
      num Events
      27
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
      num Events
      6
    term
    NAUSEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      67
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      72
      num Events
      9
    term
    ABDOMINAL PAIN
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      67
      num Events
      17
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      72
      num Events
      7
    term
    VOMITING
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      67
      num Events
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      72
      num Events
      4
    term
    DIARRHOEA
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      72
      num Events
      4
    term
    ABDOMINAL DISTENSION
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      67
      num Events
      36
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      72
      num Events
      17
    term
    FATIGUE
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      67
      num Events
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    CHILLS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      67
      num Events
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      10
    term
    PYREXIA
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      67
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      5
    term
    OEDEMA PERIPHERAL
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      67
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    PAIN
Complete source fields
description
Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
event Groups
  1. deaths Num Affected
    30
    deaths Num At Risk
    67
    description
    DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
    id
    EG000
    other Num Affected
    64
    other Num At Risk
    67
    serious Num Affected
    20
    serious Num At Risk
    67
    title
    DN24-02
  2. deaths Num Affected
    30
    deaths Num At Risk
    72
    description
    Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    72
    serious Num Affected
    17
    serious Num At Risk
    72
    title
    Standard of Care
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      67
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      6
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      67
      num Events
      15
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      72
      num Events
      10
    term
    CONSTIPATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      67
      num Events
      27
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
      num Events
      6
    term
    NAUSEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      67
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      72
      num Events
      9
    term
    ABDOMINAL PAIN
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      67
      num Events
      17
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      72
      num Events
      7
    term
    VOMITING
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      67
      num Events
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      72
      num Events
      4
    term
    DIARRHOEA
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      72
      num Events
      4
    term
    ABDOMINAL DISTENSION
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      67
      num Events
      36
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      72
      num Events
      17
    term
    FATIGUE
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      67
      num Events
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    CHILLS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      67
      num Events
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      10
    term
    PYREXIA
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      67
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      5
    term
    OEDEMA PERIPHERAL
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      67
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    PAIN
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    THROMBOCYTOPENIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    ATRIAL FIBRILLATION
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    CARDIAC FAILURE ACUTE
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    CARDIOGENIC SHOCK
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      72
      num Events
      5
    term
    SMALL INTESTINAL OBSTRUCTION
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    ABDOMINAL PAIN
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      2
    term
    INTESTINAL OBSTRUCTION
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    NAUSEA
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    VOMITING
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    DUODENAL ULCER
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    GASTROINTESTINAL NECROSIS
time Frame
Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later.

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