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NCT00360971 · ADVERSE EVENTS

Adverse events

Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer · Source last updated 2017-12-26

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%

Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Mucositis was collected separately from other AE's using the World Health Organization (WHO) grading criteria.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.

8 / 109 / 10Not reported / Not reported
Palifermin

Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.

5 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Palifermin

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
    Gastrointestinal disorders
    source Vocabulary
    WHO
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      11
    term
    Mucositis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Dry mouth
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Dysphagia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Vomiting NOS
  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
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Appendix
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Metabolic/laboratory - Other:
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
    term
    Weight decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Anorexia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Hypercalcaemia

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 (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
    term
    Hearing impaired
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    term
    Tinnitus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Endocrine - Other:
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    WHO
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      11
    term
    Mucositis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Caecitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Diarrhoea NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
    term
    Dry mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Esophageal stenosis acquired
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Gastrointestinal - Other:
Complete source fields
description
Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE). Mucositis was collected separately from other AE's using the World Health Organization (WHO) grading criteria.
event Groups
  1. description
    Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    8
    serious Num At Risk
    10
    title
    Placebo
  2. description
    Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Palifermin
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
    term
    Hemoglobin
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
    term
    Hearing impaired
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    term
    Tinnitus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Endocrine - Other:
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    WHO
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      11
    term
    Mucositis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Caecitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Diarrhoea NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
    term
    Dry mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Esophageal stenosis acquired
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Gastrointestinal - Other:
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    WHO
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      11
    term
    Mucositis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Dry mouth
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Dysphagia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Vomiting NOS
  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
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Appendix
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Metabolic/laboratory - Other:
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
    term
    Weight decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Anorexia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Hypercalcaemia

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