Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01256385 · ADVERSE EVENTS

Adverse events

Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy · Source last updated 2017-03-27

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Cetuximab and Temsirolimus)

Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

14 / 4039 / 40Not reported / Not reported
Arm B (Temsirolimus)

Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.

19 / 4037 / 40Not reported / Not reported

Group identifiers: EG000: Arm A (Cetuximab and Temsirolimus) · EG001: Arm B (Temsirolimus)

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Acute kidney injury
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Anorectal infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Aspiration
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Back pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Bone pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Bronchopulmonary hemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Death NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Dehydration
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Dizziness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
    term
    Dyspnea

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    term
    Alanine aminotransferase increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
    term
    Alkaline phosphatase increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Allergic rhinitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Alopecia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      40
    term
    Anemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      40
    term
    Anorexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Anxiety
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Arthralgia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
    term
    Aspartate aminotransferase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Back pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Blurred vision
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    CD4 lymphocytes decreased
Complete source fields
event Groups
  1. description
    Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    40
    serious Num Affected
    14
    serious Num At Risk
    40
    title
    Arm A (Cetuximab and Temsirolimus)
  2. description
    Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
    id
    EG001
    other Num Affected
    37
    other Num At Risk
    40
    serious Num Affected
    19
    serious Num At Risk
    40
    title
    Arm B (Temsirolimus)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    term
    Alanine aminotransferase increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
    term
    Alkaline phosphatase increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Allergic rhinitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Alopecia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      40
    term
    Anemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      40
    term
    Anorexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Anxiety
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    term
    Arthralgia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
    term
    Aspartate aminotransferase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Back pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Blurred vision
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    CD4 lymphocytes decreased
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Acute kidney injury
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Anorectal infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Aspiration
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Back pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Bone pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Bronchopulmonary hemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Death NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Dehydration
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Dizziness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
    term
    Dyspnea

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice