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NCT00101582 · ADVERSE EVENTS

Adverse events

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer · Source last updated 2016-09-27

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
Approximately 8 weeks
Other-event reporting threshold
5%

The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.

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

Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.

25 / 9181 / 91Not reported / Not reported
Palifermin

Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.

35 / 9489 / 94Not 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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Haemoglobinaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Hypoacusis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Dysphagia

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
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      94
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      94
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      94
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      94
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      94
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      94
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Odynophagia
Complete source fields
description
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
event Groups
  1. description
    Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
    id
    EG000
    other Num Affected
    81
    other Num At Risk
    91
    serious Num Affected
    25
    serious Num At Risk
    91
    title
    Placebo
  2. description
    Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
    id
    EG001
    other Num Affected
    89
    other Num At Risk
    94
    serious Num Affected
    35
    serious Num At Risk
    94
    title
    Palifermin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      94
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      94
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      94
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      94
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      94
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      94
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      94
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    term
    Odynophagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Haemoglobinaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    term
    Hypoacusis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      91
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    term
    Dysphagia
time Frame
Approximately 8 weeks

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