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NCT05228470 · ADVERSE EVENTS

Adverse events

A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma. · Source last updated 2026-01-06

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
AEs: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (approximately up to 16 months)
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1b

Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.

6 / 88 / 86 / 8
Phase 2

Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.

23 / 3030 / 3013 / 30
Phase 1b + Phase 2

Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.

29 / 3838 / 3819 / 38

Group identifiers: EG000: Phase 1b · EG001: Phase 2 · EG002: Phase 1b + Phase 2

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Death
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Cytokine release syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Acinetobacter bacteraemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    COVID-19

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      38
    term
    Hypoglobulinaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      38
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      38
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      38
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      38
    term
    Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Cardiac failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Sinus tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Tinnitus
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Hyperthyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Conjunctival hyperaemia
Complete source fields
description
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    6
    serious Num At Risk
    8
    title
    Phase 1b
  2. deaths Num Affected
    13
    deaths Num At Risk
    30
    description
    Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
    id
    EG001
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    23
    serious Num At Risk
    30
    title
    Phase 2
  3. deaths Num Affected
    19
    deaths Num At Risk
    38
    description
    Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8.
    id
    EG002
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    29
    serious Num At Risk
    38
    title
    Phase 1b + Phase 2
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      38
    term
    Hypoglobulinaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      38
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      38
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      38
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      38
    term
    Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Cardiac failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    Sinus tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Tinnitus
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Hyperthyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Conjunctival hyperaemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Diarrhoea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Gastrointestinal haemorrhage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Death
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
    term
    Cytokine release syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
    term
    Acinetobacter bacteraemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
    term
    COVID-19
time Frame
AEs: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (approximately up to 16 months)

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Preserved source evidence · Not medical advice