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NCT02486718 · ADVERSE EVENTS

Adverse events

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] · Source last updated 2026-07-29

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 95 months
Other-event reporting threshold
5%

Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enrollment Phase

All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.

259 / 12691153 / 126919 / 1269
Best Supportive Care (BSC)

Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

42 / 495227 / 495155 / 495
Atezolizumab

Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.

88 / 495358 / 495154 / 495

Group identifiers: EG000: Enrollment Phase · EG001: Best Supportive Care (BSC) · EG002: 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 version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      1269
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Sarcoidosis of lymph node
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1269
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      495
      num Events
      0
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1269
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      495
      num Events
      2
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Cardiac failure acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      495
      num Events
      0
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1269
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Myocarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      495
      num Events
      0
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      357
      num At Risk
      1269
      num Events
      422
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      495
      num Events
      30
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      495
      num Events
      47
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      1269
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      495
      num Events
      3
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      495
      num Events
      36
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1269
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      495
      num Events
      3
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      495
      num Events
      61
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      181
      num At Risk
      1269
      num Events
      226
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      495
      num Events
      12
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      495
      num Events
      54
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      660
      num At Risk
      1269
      num Events
      1032
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      495
      num Events
      16
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      495
      num Events
      44
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      234
      num At Risk
      1269
      num Events
      301
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      495
      num Events
      15
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      495
      num Events
      45
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      269
      num At Risk
      1269
      num Events
      309
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      495
      num Events
      14
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      495
      num Events
      41
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      1269
      num Events
      86
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      495
      num Events
      14
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      495
      num Events
      67
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      1269
      num Events
      26
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      495
      num Events
      65
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      495
      num Events
      44
    term
    Nasopharyngitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      1269
      num Events
      33
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      495
      num Events
      14
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      495
      num Events
      43
    term
    Upper respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      1269
      num Events
      57
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      495
      num Events
      17
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      495
      num Events
      71
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      1269
      num Events
      47
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      495
      num Events
      16
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      495
      num Events
      67
    term
    Aspartate aminotransferase increased
Complete source fields
description
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
event Groups
  1. deaths Num Affected
    19
    deaths Num At Risk
    1269
    description
    All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
    id
    EG000
    other Num Affected
    1153
    other Num At Risk
    1269
    serious Num Affected
    259
    serious Num At Risk
    1269
    title
    Enrollment Phase
  2. deaths Num Affected
    155
    deaths Num At Risk
    495
    description
    Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
    id
    EG001
    other Num Affected
    227
    other Num At Risk
    495
    serious Num Affected
    42
    serious Num At Risk
    495
    title
    Best Supportive Care (BSC)
  3. deaths Num Affected
    154
    deaths Num At Risk
    495
    description
    Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
    id
    EG002
    other Num Affected
    358
    other Num At Risk
    495
    serious Num Affected
    88
    serious Num At Risk
    495
    title
    Atezolizumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      357
      num At Risk
      1269
      num Events
      422
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      495
      num Events
      30
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      495
      num Events
      47
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      1269
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      495
      num Events
      3
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      495
      num Events
      36
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1269
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      495
      num Events
      3
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      495
      num Events
      61
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      181
      num At Risk
      1269
      num Events
      226
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      495
      num Events
      12
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      495
      num Events
      54
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      660
      num At Risk
      1269
      num Events
      1032
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      495
      num Events
      16
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      495
      num Events
      44
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      234
      num At Risk
      1269
      num Events
      301
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      495
      num Events
      15
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      495
      num Events
      45
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      269
      num At Risk
      1269
      num Events
      309
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      495
      num Events
      14
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      495
      num Events
      41
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      1269
      num Events
      86
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      495
      num Events
      14
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      495
      num Events
      67
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      1269
      num Events
      26
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      495
      num Events
      65
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      495
      num Events
      44
    term
    Nasopharyngitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      1269
      num Events
      33
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      495
      num Events
      14
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      495
      num Events
      43
    term
    Upper respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      1269
      num Events
      57
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      495
      num Events
      17
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      495
      num Events
      71
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      1269
      num Events
      47
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      495
      num Events
      16
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      495
      num Events
      67
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      1269
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Sarcoidosis of lymph node
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1269
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      495
      num Events
      0
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1269
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      495
      num Events
      2
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Cardiac failure acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      495
      num Events
      0
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1269
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Myocarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      495
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      495
      num Events
      0
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1269
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      495
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      495
      num Events
      1
    term
    Supraventricular tachycardia
time Frame
Up to 95 months

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Preserved source evidence · Not medical advice