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NCT02603432 · ADVERSE EVENTS

Adverse events

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) · Source last updated 2024-03-27

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
For ''Avelumab + Best Supportive Care (BSC)'' reporting group: Day 1 up to 90 days after last dose of study drug and for ''Best Supportive Care'' reporting group: Day 1 up to 90 days after end of treatment visit, for a maximum duration of up to 70 months for both groups.
Other-event reporting threshold
5%

Same event may appear as both non-SAE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-Cause Mortality, SAEs and non-SAEs were assessed in Safety Analysis set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Avelumab + Best Supportive Care (BSC)

Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.

111 / 344321 / 344225 / 344
Best Supportive Care

As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.

73 / 345214 / 345242 / 345

Group identifiers: EG000: Avelumab + Best Supportive Care (BSC) · EG001: Best Supportive 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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Acute myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Angina pectoris
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Atrial thrombosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Cardiogenic shock
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Coronary artery disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Coronary artery stenosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Myocardial infarction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Pleuropericarditis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Sinus tachycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Supraventricular tachycardia

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      345
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Hyperthyroidism
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      345
    term
    Asthenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      345
    term
    Chills
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      345
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      345
    term
    Influenza like illness
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Oedema peripheral
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      345
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      345
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      345
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      345
    term
    Diarrhoea
Complete source fields
description
Same event may appear as both non-SAE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-Cause Mortality, SAEs and non-SAEs were assessed in Safety Analysis set.
event Groups
  1. deaths Num Affected
    225
    deaths Num At Risk
    344
    description
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    EG000
    other Num Affected
    321
    other Num At Risk
    344
    serious Num Affected
    111
    serious Num At Risk
    344
    title
    Avelumab + Best Supportive Care (BSC)
  2. deaths Num Affected
    242
    deaths Num At Risk
    345
    description
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    EG001
    other Num Affected
    214
    other Num At Risk
    345
    serious Num Affected
    73
    serious Num At Risk
    345
    title
    Best Supportive Care
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      345
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Hyperthyroidism
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      345
    term
    Asthenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      345
    term
    Chills
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      345
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      345
    term
    Influenza like illness
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      345
    term
    Oedema peripheral
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      345
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      345
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      345
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      345
    term
    Diarrhoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      345
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Acute myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Angina pectoris
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Atrial thrombosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
    term
    Cardiogenic shock
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Coronary artery disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Coronary artery stenosis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Myocardial infarction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Pleuropericarditis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Sinus tachycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      344
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
    term
    Supraventricular tachycardia
time Frame
For ''Avelumab + Best Supportive Care (BSC)'' reporting group: Day 1 up to 90 days after last dose of study drug and for ''Best Supportive Care'' reporting group: Day 1 up to 90 days after end of treatment visit, for a maximum duration of up to 70 months for both groups.

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