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NCT00720304 · ADVERSE EVENTS

Adverse events

Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck · Source last updated 2024-08-22

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
Up to 3 years
Other-event reporting threshold
0%

Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oral Erlotinib Hydrochloride

Docetaxel, erlotinib hydrochloride, fluorescence in situ hybridization, polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, therapeutic conventional surgery, intensity-modulated radiation therapy, radiation therapy

11 / 3733 / 3711 / 37
Participants From CWRU1301

Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT

1 / 66 / 64 / 6

Group identifiers: EG000: Oral Erlotinib Hydrochloride · EG001: Participants From CWRU1301

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
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Palpitations
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Cardiac ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dysphagia (difficulty swallowing)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dyspnea (shortness of breath)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Glucose, serum-high (hyperglycemia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hemorrhage, GI - Lower GI
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypotension

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
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      37
      num Events
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      6
      num Events
      33
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Supraventricular and nodal arrhythmia - Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain - External ear
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain - Eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain - Middle ear
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Auditory congestion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Auditory blockage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thyroid function, low (hypothyroidism)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Endocrine - increased TSH
Complete source fields
description
Toxicity assessment performed at baseline, every two weeks until week 10, and then monthly until off-study (up to 3 years)
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    37
    description
    Docetaxel, erlotinib hydrochloride, fluorescence in situ hybridization, polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study, therapeutic conventional surgery, intensity-modulated radiation therapy, radiation therapy
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    37
    serious Num Affected
    11
    serious Num At Risk
    37
    title
    Oral Erlotinib Hydrochloride
  2. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants from CWRU1301 - NCT00049283 who received Docetaxel 20 mg/m2/wk Erlotinib 150 mg/day XRT
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Participants From CWRU1301
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      37
      num Events
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      6
      num Events
      33
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      37
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Supraventricular and nodal arrhythmia - Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain - External ear
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain - Eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain - Middle ear
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Auditory congestion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Auditory blockage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thyroid function, low (hypothyroidism)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Endocrine - increased TSH
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Palpitations
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Cardiac ischemia/infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dysphagia (difficulty swallowing)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dyspnea (shortness of breath)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      37
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Glucose, serum-high (hyperglycemia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hemorrhage, GI - Lower GI
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypotension
time Frame
Up to 3 years

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