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NCT02155647 · ADVERSE EVENTS

Adverse events

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13

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
Part A: Up to 325 weeks; Part B: Up to 396 weeks
Other-event reporting threshold
5%

Adverse events were reported as per MedDRA v21.1 for Part A arm and MedDRA v22.0 for Part B.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: Avelumab

Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

48 / 8886 / 8863 / 88
Part B: Avelumab

Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

58 / 116114 / 11672 / 116

Group identifiers: EG000: Part A: Avelumab · EG001: Part B: Avelumab

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 v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      116
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Microcytic anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Normochromic normocytic anaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Atrial flutter
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Eyelid function disorder
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Glaucoma
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Retinal artery occlusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Ulcerative keratitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      116
    term
    Abdominal pain

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 v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      116
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      116
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      116
    term
    Eosinophilia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      116
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      116
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      116
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      116
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      116
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      116
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      116
    term
    Chills
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      116
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      116
    term
    Oedema peripheral
Complete source fields
description
Adverse events were reported as per MedDRA v21.1 for Part A arm and MedDRA v22.0 for Part B.
event Groups
  1. deaths Num Affected
    63
    deaths Num At Risk
    88
    description
    Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
    id
    EG000
    other Num Affected
    86
    other Num At Risk
    88
    serious Num Affected
    48
    serious Num At Risk
    88
    title
    Part A: Avelumab
  2. deaths Num Affected
    72
    deaths Num At Risk
    116
    description
    Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
    id
    EG001
    other Num Affected
    114
    other Num At Risk
    116
    serious Num Affected
    58
    serious Num At Risk
    116
    title
    Part B: Avelumab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      116
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      116
    term
    Lymphopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      116
    term
    Eosinophilia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      116
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      116
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      116
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      116
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      116
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      116
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      116
    term
    Chills
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      116
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      116
    term
    Oedema peripheral
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      116
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Microcytic anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Normochromic normocytic anaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Atrial flutter
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Eyelid function disorder
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Glaucoma
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Retinal artery occlusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      116
    term
    Ulcerative keratitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v21.1and 22.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      88
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      116
    term
    Abdominal pain
time Frame
Part A: Up to 325 weeks; Part B: Up to 396 weeks

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