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NCT00085202 · ADVERSE EVENTS

Adverse events

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor · Source last updated 2024-02-08

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
Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.
Other-event reporting threshold
5%

Per protocol, Grade 3 and 4 hematologic toxicities, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected if they occurred from the beginning of radiation therapy through the end of 4 courses of high dose chemotherapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Average-Risk Group

Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2).

17 / 269236 / 269Not reported / Not reported
High-Risk Group

Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery.

17 / 144118 / 144Not reported / Not reported

Group identifiers: EG000: Average-Risk Group · EG001: High-Risk Group

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Supraventricular and nodal arrhythmia - sinus bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Cardiac general - other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Pericardial effusion (non-malignant)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    e.g., thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Thrombotic microangiopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Death not associated with CTCAE term, death NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Hemorrhage/bleeding - other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Cholecystitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Pancreatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      269
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Febrile neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Infection, blood
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      144
      num Events
      2
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, blood

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
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      172
      num At Risk
      269
      num Events
      383
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      144
      num Events
      148
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      269
      num Events
      76
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      144
      num Events
      28
    term
    Infection, blood
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      269
      num Events
      63
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      144
      num Events
      29
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      269
      num Events
      54
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      144
      num Events
      32
    term
    Allergic reaction/hypersensitivity (including drug fever)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      269
      num Events
      37
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      144
      num Events
      30
    term
    Pain, abdomen NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      269
      num Events
      30
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      144
      num Events
      23
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      269
      num Events
      33
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      144
      num Events
      19
    term
    Infection - other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      269
      num Events
      36
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      144
      num Events
      16
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      269
      num Events
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      144
      num Events
      8
    term
    Colitis, infectious (e.g., Clostridium difficile)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      269
      num Events
      30
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      144
      num Events
      11
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, blood
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      269
      num Events
      17
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      144
      num Events
      13
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      269
      num Events
      23
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      144
      num Events
      19
    term
    Infection with unknown ANC, blood
Complete source fields
description
Per protocol, Grade 3 and 4 hematologic toxicities, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected if they occurred from the beginning of radiation therapy through the end of 4 courses of high dose chemotherapy.
event Groups
  1. description
    Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was \<1.5 cm\^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \<1.5 cm\^2).
    id
    EG000
    other Num Affected
    236
    other Num At Risk
    269
    serious Num Affected
    17
    serious Num At Risk
    269
    title
    Average-Risk Group
  2. description
    Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm\^2) at the primary site after surgery.
    id
    EG001
    other Num Affected
    118
    other Num At Risk
    144
    serious Num Affected
    17
    serious Num At Risk
    144
    title
    High-Risk Group
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      172
      num At Risk
      269
      num Events
      383
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      144
      num Events
      148
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      269
      num Events
      76
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      144
      num Events
      28
    term
    Infection, blood
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      269
      num Events
      63
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      144
      num Events
      29
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      269
      num Events
      54
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      144
      num Events
      32
    term
    Allergic reaction/hypersensitivity (including drug fever)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      269
      num Events
      37
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      144
      num Events
      30
    term
    Pain, abdomen NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      269
      num Events
      30
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      144
      num Events
      23
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      269
      num Events
      33
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      144
      num Events
      19
    term
    Infection - other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      269
      num Events
      36
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      144
      num Events
      16
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      269
      num Events
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      144
      num Events
      8
    term
    Colitis, infectious (e.g., Clostridium difficile)
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      269
      num Events
      30
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      144
      num Events
      11
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, blood
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      269
      num Events
      17
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      144
      num Events
      13
    term
    Anorexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      269
      num Events
      23
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      144
      num Events
      19
    term
    Infection with unknown ANC, blood
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Supraventricular and nodal arrhythmia - sinus bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Cardiac general - other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Pericardial effusion (non-malignant)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    e.g., thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Thrombotic microangiopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Death not associated with CTCAE term, death NOS
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Hemorrhage/bleeding - other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      144
      num Events
      1
    term
    Cholecystitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Pancreatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      269
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Febrile neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L).
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      269
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      144
      num Events
      0
    term
    Infection, blood
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      269
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      144
      num Events
      2
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, blood
time Frame
Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.

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Preserved source evidence · Not medical advice