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NCT00410826 · ADVERSE EVENTS

Adverse events

Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2013-05-10

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
Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy.
Other-event reporting threshold
5%

All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Cisplatin and Radiotherapy)

Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.

32 / 9687 / 96Not reported / Not reported
Arm B (Cisplatin, Radiotherapy, Erlotinib)

Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.

38 / 9591 / 95Not reported / Not reported

Group identifiers: EG000: Arm A (Cisplatin and Radiotherapy) · EG001: Arm B (Cisplatin, Radiotherapy, Erlotinib)

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
    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
      96
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
    term
    hearing loss
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    Cytopenias
  3. 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
      96
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      95
    term
    nausea,vomiting, dehydration
  4. 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
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      95
    term
    mucositis, esophagitis
  5. 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
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    peritonitis, perforation
  6. 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
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    hyponatremia
  7. 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
      96
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      95
    term
    elevated creatinine
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      95
    term
    pneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      95
    term
    Pulmonary embolism, deep vein thrombosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    mood alteration
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      95
    term
    Substance abuse, seizure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      95
    term
    congestive heart disease, cardiac arrest

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      95
    term
    dermatitis, rash
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      95
    term
    pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      95
    term
    mucositis, nausea, vomiting, dehydration
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      95
    term
    Cytopenias
Complete source fields
description
All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.
event Groups
  1. description
    Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
    id
    EG000
    other Num Affected
    87
    other Num At Risk
    96
    serious Num Affected
    32
    serious Num At Risk
    96
    title
    Arm A (Cisplatin and Radiotherapy)
  2. description
    Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
    id
    EG001
    other Num Affected
    91
    other Num At Risk
    95
    serious Num Affected
    38
    serious Num At Risk
    95
    title
    Arm B (Cisplatin, Radiotherapy, Erlotinib)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      95
    term
    dermatitis, rash
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      95
    term
    pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      95
    term
    mucositis, nausea, vomiting, dehydration
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      95
    term
    Cytopenias
serious Events
  1. 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
      96
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      95
    term
    hearing loss
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    Cytopenias
  3. 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
      96
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      95
    term
    nausea,vomiting, dehydration
  4. 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
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      95
    term
    mucositis, esophagitis
  5. 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
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    peritonitis, perforation
  6. 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
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    hyponatremia
  7. 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
      96
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      95
    term
    elevated creatinine
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      95
    term
    pneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      95
    term
    Pulmonary embolism, deep vein thrombosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      95
    term
    mood alteration
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      95
    term
    Substance abuse, seizure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      95
    term
    congestive heart disease, cardiac arrest
time Frame
Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy.

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Preserved source evidence · Not medical advice