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NCT01682031 · ADVERSE EVENTS

Adverse events

Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy · Source last updated 2014-08-22

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Placebo, Cisplatin, and Radiotherapy)

Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies

4 / 88 / 8Not reported / Not reported
Arm II (Selenomethionine, Cisplatin, and Radiotherapy)

Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies

2 / 1010 / 10Not reported / Not reported

Group identifiers: EG000: Arm I (Placebo, Cisplatin, and Radiotherapy) · EG001: Arm II (Selenomethionine, Cisplatin, and Radiotherapy)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ventricular tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Mucosal inflammation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Blood creatine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Blood sodium abnormal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Haemoglobin decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Neutrophil count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cerebrovascular accident

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      9
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      27
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    White blood cell disorder
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Deafness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ear pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hypoacusis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Otorrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      12
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Diplopia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      24
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
      num Events
      30
    term
    Constipation
Complete source fields
event Groups
  1. description
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Arm I (Placebo, Cisplatin, and Radiotherapy)
  2. description
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      9
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      27
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    White blood cell disorder
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Deafness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ear pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hypoacusis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Otorrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      12
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Diplopia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      24
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
      num Events
      30
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ventricular tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Mucosal inflammation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Blood creatine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Blood sodium abnormal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Haemoglobin decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Neutrophil count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      3
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cerebrovascular accident

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