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NCT02302807 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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
From the first study drug to the data cutoff date: 8 Nov 2018 (up to 46 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

189 / 443417 / 443393 / 443
Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

192 / 459413 / 459379 / 459

Group identifiers: EG000: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) · EG001: Atezolizumab

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
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      443
      num Events
      5
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      459
      num Events
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      443
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Bone Marrow Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      443
      num Events
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      459
      num Events
      1
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      443
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      459
      num Events
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      443
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Acute Coronary Syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      443
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      459
      num Events
      2
    term
    Acute Myocardial Infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Angina Pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      443
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      459
      num Events
      1
    term
    Atrial Fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Atrioventricular Block
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      443
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      459
      num Events
      2
    term
    Cardiac Arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Cardio-Respiratory Arrest

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      124
      num At Risk
      443
      num Events
      142
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      459
      num Events
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      443
      num Events
      75
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      459
      num Events
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      443
      num Events
      63
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      459
      num Events
      60
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      443
      num Events
      32
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      459
      num Events
      23
    term
    Abdominal Pain Upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      163
      num At Risk
      443
      num Events
      221
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      459
      num Events
      147
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      443
      num Events
      115
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      459
      num Events
      145
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      443
      num Events
      8
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      459
      num Events
      36
    term
    Dry Mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      137
      num At Risk
      443
      num Events
      171
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      459
      num Events
      124
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      443
      num Events
      41
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      459
      num Events
      16
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      443
      num Events
      108
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      459
      num Events
      67
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      443
      num Events
      144
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      459
      num Events
      108
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      443
      num Events
      162
    2. group Id
      EG001
      num Affected
      129
      num At Risk
      459
      num Events
      153
    term
    Fatigue
Complete source fields
event Groups
  1. deaths Num Affected
    393
    deaths Num At Risk
    443
    description
    Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
    id
    EG000
    other Num Affected
    417
    other Num At Risk
    443
    serious Num Affected
    189
    serious Num At Risk
    443
    title
    Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
  2. deaths Num Affected
    379
    deaths Num At Risk
    459
    description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    EG001
    other Num Affected
    413
    other Num At Risk
    459
    serious Num Affected
    192
    serious Num At Risk
    459
    title
    Atezolizumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      124
      num At Risk
      443
      num Events
      142
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      459
      num Events
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      443
      num Events
      75
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      459
      num Events
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      443
      num Events
      63
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      459
      num Events
      60
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      443
      num Events
      32
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      459
      num Events
      23
    term
    Abdominal Pain Upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      163
      num At Risk
      443
      num Events
      221
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      459
      num Events
      147
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      443
      num Events
      115
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      459
      num Events
      145
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      443
      num Events
      8
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      459
      num Events
      36
    term
    Dry Mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      137
      num At Risk
      443
      num Events
      171
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      459
      num Events
      124
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      443
      num Events
      41
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      459
      num Events
      16
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      443
      num Events
      108
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      459
      num Events
      67
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      443
      num Events
      144
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      459
      num Events
      108
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      443
      num Events
      162
    2. group Id
      EG001
      num Affected
      129
      num At Risk
      459
      num Events
      153
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      443
      num Events
      5
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      459
      num Events
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      443
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Bone Marrow Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      443
      num Events
      25
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      459
      num Events
      1
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      443
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      459
      num Events
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      443
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Acute Coronary Syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      443
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      459
      num Events
      2
    term
    Acute Myocardial Infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Angina Pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      443
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      459
      num Events
      1
    term
    Atrial Fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Atrioventricular Block
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      443
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      459
      num Events
      2
    term
    Cardiac Arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      443
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      459
      num Events
      0
    term
    Cardio-Respiratory Arrest
time Frame
From the first study drug to the data cutoff date: 8 Nov 2018 (up to 46 months)

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