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NCT02101788 · ADVERSE EVENTS

Adverse events

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer · Source last updated 2026-08-04

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
Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A - Control Arm

Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days

43 / 127124 / 12760 / 127
Arm B - Experimental Arm

Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days

45 / 127127 / 12751 / 127
Crossover From Control to Experimental Arm

Patients randomized to the control arm who crossed over to the experimental arm after disease progression.

25 / 8888 / 883 / 88

Group identifiers: EG000: Arm A - Control Arm · EG001: Arm B - Experimental Arm · EG002: Crossover From Control to Experimental Arm

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Eye Disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Retinal Vascular Disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      88
    term
    Colonic Obstruction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Colonic Stenosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Colonic Perforation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      88
    term
    Small Intestinal Obstruction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      88
    term
    Abdominal Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Mucositis Oral
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Lower Gastrointestinal Hemorrhage

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Thrombotic Thrombocytopenic Purpura
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Lymph Node Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      88
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Febrile Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Atrial Fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Ventricular Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Conduction Disorder
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Sinus Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Palpitations
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Left Ventricular Systolic Dysfunction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Acute Coronary Syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Pulmonary Valve Disease
Complete source fields
event Groups
  1. deaths Num Affected
    60
    deaths Num At Risk
    127
    description
    Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
    id
    EG000
    other Num Affected
    124
    other Num At Risk
    127
    serious Num Affected
    43
    serious Num At Risk
    127
    title
    Arm A - Control Arm
  2. deaths Num Affected
    51
    deaths Num At Risk
    127
    description
    Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
    id
    EG001
    other Num Affected
    127
    other Num At Risk
    127
    serious Num Affected
    45
    serious Num At Risk
    127
    title
    Arm B - Experimental Arm
  3. deaths Num Affected
    3
    deaths Num At Risk
    88
    description
    Patients randomized to the control arm who crossed over to the experimental arm after disease progression.
    id
    EG002
    other Num Affected
    88
    other Num At Risk
    88
    serious Num Affected
    25
    serious Num At Risk
    88
    title
    Crossover From Control to Experimental Arm
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Thrombotic Thrombocytopenic Purpura
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Lymph Node Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      88
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Febrile Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Atrial Fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Ventricular Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Conduction Disorder
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Sinus Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Palpitations
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Left Ventricular Systolic Dysfunction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Acute Coronary Syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Pulmonary Valve Disease
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Eye Disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Retinal Vascular Disorder
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      88
    term
    Colonic Obstruction
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Colonic Stenosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Colonic Perforation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      88
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      88
    term
    Small Intestinal Obstruction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      88
    term
    Abdominal Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Mucositis Oral
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      127
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      88
    term
    Lower Gastrointestinal Hemorrhage
time Frame
Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.

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Preserved source evidence · Not medical advice