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NCT02007200 · ADVERSE EVENTS

Adverse events

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery · Source last updated 2016-10-24

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
Not reported
Other-event reporting threshold
0%

55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Soy Isoflavones)

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

7 / 5225 / 52Not reported / Not reported

Group identifiers: EG000: Treatment (Soy Isoflavones)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Nausea
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Infection, Lung
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Infection, Wound
  5. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Pain, Bone
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Acute Respiratory Distress Syndrome

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      24
    term
    Hemoglobin
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Leukocytes (total WBC)
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      4
    term
    Lymphopenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Platelets
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      5
    term
    Fatigue (asthenia, lethargy, malaise)
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      2
    term
    Fever in the absence of neutropenia
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Sweating (diaphoresis)
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      5
    term
    Weight gain
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      4
    term
    Weight loss
  10. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dermatology/Skin - Other
  11. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Flushing
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Anorexia
Complete source fields
description
55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.
event Groups
  1. description
    Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    52
    serious Num Affected
    7
    serious Num At Risk
    52
    title
    Treatment (Soy Isoflavones)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      24
    term
    Hemoglobin
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Leukocytes (total WBC)
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      4
    term
    Lymphopenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Platelets
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      5
    term
    Fatigue (asthenia, lethargy, malaise)
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      2
    term
    Fever in the absence of neutropenia
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Sweating (diaphoresis)
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      5
    term
    Weight gain
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      4
    term
    Weight loss
  10. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Dermatology/Skin - Other
  11. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Flushing
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Anorexia
serious Events
  1. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Cardiopulmonary arrest, cause unknown (non-fatal)
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Nausea
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Infection, Lung
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Infection, Wound
  5. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Pain, Bone
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other
  7. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Acute Respiratory Distress Syndrome

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Preserved source evidence · Not medical advice