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NCT02773849 · ADVERSE EVENTS

Adverse events

ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) · Source last updated 2024-07-29

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
60 months
Other-event reporting threshold
5%

The Month 60 final dataset was used for all Adverse Event Reporting data.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Carcinoma in Situ (CIS)

Patients had at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only or Ta/T1 high-grade disease with concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.

10 / 107101 / 10721 / 107
Papillary Disease (Without Concomitant CIS)

Patients had at entry, confirmed by a pathology report Ta/T1 high-grade disease without concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with high-grade Ta/T1 high-grade disease without concomitant CIS within 12 months of their last intravesical treatment with BCG or relapsed with high- grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.

9 / 5045 / 505 / 50
Total TEAE

Total Treatment-Emergent Adverse Events (TEAE) in the Study.

19 / 157146 / 15726 / 157

Group identifiers: EG000: Carcinoma in Situ (CIS) · EG001: Papillary Disease (Without Concomitant CIS) · EG002: Total TEAE

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
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Arrhythmia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      157
      num Events
      2
    term
    Coronary Artery Disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      2
    term
    Pericarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Bile duct stone
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Anaphylactic reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      157
      num Events
      2
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Corneal abrasion

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      50
      num Events
      5
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      157
      num Events
      7
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      157
      num Events
      3
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      107
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      7
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      157
      num Events
      17
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
      num Events
      4
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      157
      num Events
      12
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      157
      num Events
      6
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      107
      num Events
      18
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
      num Events
      6
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      157
      num Events
      24
    term
    Chills
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      107
      num Events
      29
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
      num Events
      8
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      157
      num Events
      37
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
      num Events
      4
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      157
      num Events
      8
    term
    Influenza like illness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      107
      num Events
      37
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      50
      num Events
      15
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      157
      num Events
      52
    term
    Instillation site discharge
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      157
      num Events
      6
    term
    Malaise
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      157
      num Events
      11
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      107
      num Events
      18
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      7
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      157
      num Events
      25
    term
    Pyrexia
Complete source fields
description
The Month 60 final dataset was used for all Adverse Event Reporting data.
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    107
    description
    Patients had at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only or Ta/T1 high-grade disease with concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.
    id
    EG000
    other Num Affected
    101
    other Num At Risk
    107
    serious Num Affected
    10
    serious Num At Risk
    107
    title
    Carcinoma in Situ (CIS)
  2. deaths Num Affected
    5
    deaths Num At Risk
    50
    description
    Patients had at entry, confirmed by a pathology report Ta/T1 high-grade disease without concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with high-grade Ta/T1 high-grade disease without concomitant CIS within 12 months of their last intravesical treatment with BCG or relapsed with high- grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.
    id
    EG001
    other Num Affected
    45
    other Num At Risk
    50
    serious Num Affected
    9
    serious Num At Risk
    50
    title
    Papillary Disease (Without Concomitant CIS)
  3. deaths Num Affected
    26
    deaths Num At Risk
    157
    description
    Total Treatment-Emergent Adverse Events (TEAE) in the Study.
    id
    EG002
    other Num Affected
    146
    other Num At Risk
    157
    serious Num Affected
    19
    serious Num At Risk
    157
    title
    Total TEAE
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      50
      num Events
      5
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      157
      num Events
      7
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      157
      num Events
      3
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      107
      num Events
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      7
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      157
      num Events
      17
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
      num Events
      4
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      157
      num Events
      12
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      107
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      157
      num Events
      6
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      107
      num Events
      18
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
      num Events
      6
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      157
      num Events
      24
    term
    Chills
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      107
      num Events
      29
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
      num Events
      8
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      157
      num Events
      37
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      107
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
      num Events
      4
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      157
      num Events
      8
    term
    Influenza like illness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      107
      num Events
      37
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      50
      num Events
      15
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      157
      num Events
      52
    term
    Instillation site discharge
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      157
      num Events
      6
    term
    Malaise
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      107
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      157
      num Events
      11
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      107
      num Events
      18
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      50
      num Events
      7
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      157
      num Events
      25
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Arrhythmia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      157
      num Events
      2
    term
    Coronary Artery Disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      2
    term
    Pericarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Bile duct stone
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Anaphylactic reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      157
      num Events
      2
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      157
      num Events
      1
    term
    Corneal abrasion
time Frame
60 months

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Preserved source evidence · Not medical advice