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NCT01064479 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck · Source last updated 2024-07-16

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
From the first dose through 30 days after the last does of study medication, up to 5 years
Other-event reporting threshold
5%

MedDRA v12

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)

Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.

21 / 6056 / 6037 / 60
Arm B (Combination Chemotherapy and Placebo)

Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.

46 / 5955 / 5953 / 59

Group identifiers: EG000: Arm A (Combination Chemotherapy and Erlotinib Hydrochloride) · EG001: Arm B (Combination Chemotherapy and Placebo)

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
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    term
    Oral pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    term
    Syncope
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    term
    Skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
    term
    Anemia

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      59
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      59
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      59
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      59
    term
    Mucositis oral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      59
    term
    Rash maculo-papular
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      59
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      59
    term
    Dry skin
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    term
    Rash acneform
Complete source fields
description
MedDRA v12
event Groups
  1. deaths Num Affected
    37
    deaths Num At Risk
    60
    description
    Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    60
    serious Num Affected
    21
    serious Num At Risk
    60
    title
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
  2. deaths Num Affected
    53
    deaths Num At Risk
    59
    description
    Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    59
    serious Num Affected
    46
    serious Num At Risk
    59
    title
    Arm B (Combination Chemotherapy and Placebo)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      59
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      59
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      59
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      59
    term
    Mucositis oral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      59
    term
    Rash maculo-papular
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      59
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      59
    term
    Dry skin
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
    term
    Rash acneform
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    term
    Oral pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    term
    Syncope
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    term
    Skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
    term
    Anemia
time Frame
From the first dose through 30 days after the last does of study medication, up to 5 years

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Preserved source evidence · Not medical advice