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NCT02367456 · ADVERSE EVENTS

Adverse events

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients · Source last updated 2024-01-19

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
maximum of approximately 15 months in the LIC cohort, 23 months in the AML cohort, and 40 months in the MDS cohort
Other-event reporting threshold
5%

The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lead-in Cohort

Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.

9 / 1212 / 129 / 12
AML Cohort

Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

24 / 3029 / 3025 / 30
MDS Cohort

Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

19 / 3029 / 3017 / 30

Group identifiers: EG000: Lead-in Cohort · EG001: AML Cohort · EG002: MDS Cohort

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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Acute myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Disease progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Bacteraemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Bronchopulmonary aspergillosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Catheter site cellulitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Cellulitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Cystitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Lower respiratory tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Neutropenic sepsis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Osteomyelitis

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 v24.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Ear pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Vision blurred
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    term
    Tinnitus
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Asthenia
Complete source fields
description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    12
    description
    Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    9
    serious Num At Risk
    12
    title
    Lead-in Cohort
  2. deaths Num Affected
    25
    deaths Num At Risk
    30
    description
    Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
    id
    EG001
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    24
    serious Num At Risk
    30
    title
    AML Cohort
  3. deaths Num Affected
    17
    deaths Num At Risk
    30
    description
    Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
    id
    EG002
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    19
    serious Num At Risk
    30
    title
    MDS Cohort
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Ear pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Vision blurred
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    term
    Tinnitus
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Asthenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Acute myocardial infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Abdominal pain
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Disease progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Bacteraemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Bronchopulmonary aspergillosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Catheter site cellulitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
    term
    Cellulitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Cystitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Lower respiratory tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Neutropenic sepsis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    term
    Osteomyelitis
time Frame
maximum of approximately 15 months in the LIC cohort, 23 months in the AML cohort, and 40 months in the MDS cohort

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Preserved source evidence · Not medical advice