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NCT00462735 · ADVERSE EVENTS

Adverse events

Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer · Source last updated 2018-03-13

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
Advanced Head and Neck Cancer

Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck

33 / 3333 / 33Not reported / Not reported

Group identifiers: EG000: Advanced Head and Neck Cancer

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
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      33
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      33
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    term
    Low Absolute neutrophil count
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    term
    Low White blood count
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    term
    Low Hemoglobin count
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Low Platelets count

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
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      33
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      33
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      33
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      33
    term
    Xerostomia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      33
    term
    Low Absolute neutrophil count
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      33
    term
    Low White blood count
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      33
    term
    Low Hemoglobin count
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      33
    term
    Low Platelet count
Complete source fields
event Groups
  1. description
    Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    33
    serious Num Affected
    33
    serious Num At Risk
    33
    title
    Advanced Head and Neck Cancer
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      33
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      33
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      33
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      33
    term
    Xerostomia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      33
    term
    Low Absolute neutrophil count
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      33
    term
    Low White blood count
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      33
    term
    Low Hemoglobin count
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      33
    term
    Low Platelet count
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      33
    term
    Mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
    term
    Dermatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      33
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
    term
    Low Absolute neutrophil count
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    term
    Low White blood count
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      33
    term
    Low Hemoglobin count
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
    term
    Low Platelets count

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Preserved source evidence · Not medical advice