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NCT03194867 · ADVERSE EVENTS

Adverse events

Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients · Source last updated 2024-06-14

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
TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months. All-Cause Mortality was reported for the whole study duration, approximately 62 months
Other-event reporting threshold
5%

Analysis was performed on the Safety population (tabulated according to treatment actually received \[as treated\]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Isatuximab+Cemiplimab Q2W

Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

1 / 33 / 31 / 3
Phase 2: Isatuximab

Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

17 / 3331 / 3320 / 33
Phase 2: Isatuximab + CemiplimabQ2W

Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

17 / 3734 / 3723 / 37
Phase 2:Isatuximab + CemiplimabQ4W

Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.

21 / 3527 / 3522 / 35

Group identifiers: EG000: Phase 1: Isatuximab+Cemiplimab Q2W · EG001: Phase 2: Isatuximab · EG002: Phase 2: Isatuximab + CemiplimabQ2W · EG003: Phase 2:Isatuximab + CemiplimabQ4W

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
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Covid-19 Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Catheter Site Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Encephalitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Encephalomyelitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Escherichia Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Herpes Zoster Disseminated
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Lower Respiratory Tract Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Osteomyelitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Parainfluenzae Virus Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      35
      num Events
      5
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Pneumonia Staphylococcal

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
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      35
      num Events
      5
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    Labyrinthitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      4
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    Oral Candidiasis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Sinusitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      37
      num Events
      9
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      35
      num Events
      13
    term
    Upper Respiratory Tract Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Urinary Tract Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Viral Upper Respiratory Tract Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      8
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Neutropenia
Complete source fields
description
Analysis was performed on the Safety population (tabulated according to treatment actually received \[as treated\]). There were 2 participants randomized in group isatuximab and isatuximab + cemiplimabQ4W respectively and who took another treatment/schedule.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 in all cycles every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1: Isatuximab+Cemiplimab Q2W
  2. deaths Num Affected
    20
    deaths Num At Risk
    33
    description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    33
    serious Num Affected
    17
    serious Num At Risk
    33
    title
    Phase 2: Isatuximab
  3. deaths Num Affected
    23
    deaths Num At Risk
    37
    description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    EG002
    other Num Affected
    34
    other Num At Risk
    37
    serious Num Affected
    17
    serious Num At Risk
    37
    title
    Phase 2: Isatuximab + CemiplimabQ2W
  4. deaths Num Affected
    22
    deaths Num At Risk
    35
    description
    Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    EG003
    other Num Affected
    27
    other Num At Risk
    35
    serious Num Affected
    21
    serious Num At Risk
    35
    title
    Phase 2:Isatuximab + CemiplimabQ4W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      35
      num Events
      5
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    Labyrinthitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      4
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    Oral Candidiasis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Sinusitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      37
      num Events
      9
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      35
      num Events
      13
    term
    Upper Respiratory Tract Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Urinary Tract Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Viral Upper Respiratory Tract Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      8
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Neutropenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Covid-19 Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Catheter Site Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Encephalitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Encephalomyelitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Escherichia Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Herpes Zoster Disseminated
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      33
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Influenza
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Lower Respiratory Tract Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Osteomyelitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      33
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Parainfluenzae Virus Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      33
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      35
      num Events
      5
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      33
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Pneumonia Staphylococcal
time Frame
TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months. All-Cause Mortality was reported for the whole study duration, approximately 62 months

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Preserved source evidence · Not medical advice