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NCT04892446 · ADVERSE EVENTS

Adverse events

Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2025-05-02

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
All-cause mortality: Up to 1.5 years; Adverse events: Up to 1.3 years plus 70 days
Other-event reporting threshold
5%

All-cause mortality: The All Enrolled Analysis Set included all participants who received a study patient identification number in study after screening. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study treatment with treatment group designated according to the actual treatment received. Per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Magrolimab+Daratumumab

Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received daratumumab 1800 mg SC or 16 mg/kg IV on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2; and Days 1, 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days).

5 / 1414 / 144 / 15
Magrolimab+Pomalidomide+Dexamethasone

Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received pomalidomide orally 4 mg on Days 1 to 21 (daily) of Cycle 1 and onward and dexamethasone orally 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days).

5 / 1010 / 104 / 10
Magrolimab+Carfilzomib+Dexamethasone

Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received carfilzomib IV 20 mg/m\^2 on Days 8, 15, 22 of Cycle 1; Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m\^2 was tolerated after Cycle 1, Day 8, the dose was escalated to 70 mg/m\^2 on Cycle 1, Day 15 and thereafter) and dexamethasone orally or IV 40 mg on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).

4 / 1111 / 110 / 11

Group identifiers: EG000: Magrolimab+Daratumumab · EG001: Magrolimab+Pomalidomide+Dexamethasone · EG002: Magrolimab+Carfilzomib+Dexamethasone

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 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Acute sinusitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Bacteraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Covid-19 pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Febrile infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Klebsiella urinary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Upper respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Hip fracture
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Infusion related reaction

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 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Haemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Vertigo
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Eye pain
Complete source fields
description
All-cause mortality: The All Enrolled Analysis Set included all participants who received a study patient identification number in study after screening. Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study treatment with treatment group designated according to the actual treatment received. Per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    15
    description
    Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received daratumumab 1800 mg SC or 16 mg/kg IV on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2; and Days 1, 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days).
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Magrolimab+Daratumumab
  2. deaths Num Affected
    4
    deaths Num At Risk
    10
    description
    Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received pomalidomide orally 4 mg on Days 1 to 21 (daily) of Cycle 1 and onward and dexamethasone orally 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days).
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Magrolimab+Pomalidomide+Dexamethasone
  3. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received carfilzomib IV 20 mg/m\^2 on Days 8, 15, 22 of Cycle 1; Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m\^2 was tolerated after Cycle 1, Day 8, the dose was escalated to 70 mg/m\^2 on Cycle 1, Day 15 and thereafter) and dexamethasone orally or IV 40 mg on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Magrolimab+Carfilzomib+Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Haemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Vertigo
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Eye pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Acute sinusitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Bacteraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Covid-19 pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Febrile infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Klebsiella urinary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Upper respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Hip fracture
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Infusion related reaction
time Frame
All-cause mortality: Up to 1.5 years; Adverse events: Up to 1.3 years plus 70 days

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Preserved source evidence · Not medical advice