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NCT00859937 · ADVERSE EVENTS

Adverse events

Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors · Source last updated 2018-04-20

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 5 years
Other-event reporting threshold
5%

All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Adenoid Cystic Carcinoma

Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

12 / 4039 / 40Not reported / Not reported
Non Adenoid Cystic Carcinoma

Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

8 / 1413 / 14Not reported / Not reported

Group identifiers: EG000: Adenoid Cystic Carcinoma · EG001: Non Adenoid Cystic Carcinoma

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Alanine aminotransferase increased
  2. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Anorexia
  3. organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cauda equina syndrome
  4. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Chest pain
  5. organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Confusion
  6. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Death
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Dysphagia
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Dyspnea
  9. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Hyperglycemia
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Hypoxia
  11. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Infections and infestations
  12. organ System
    Eye disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Loss of vision

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Abdominal distension
  2. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Activated partial thromboplastin time prolonged
  3. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      14
    term
    Alanine aminotransferase increased
  4. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Alkaline phosphatase increased
  5. organ System
    Immune system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Allergic reaction
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Allergic rhinitis
  7. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Alopecia
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
    term
    Anemia
  9. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Anorexia
  10. organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Anxiety
  11. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Arthralgia
  12. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
    term
    Aspartate aminotransferase increased
Complete source fields
description
All serious adverse events were reported. Other adverse events occurring in ≥5% of the study subjects were reported.
event Groups
  1. description
    Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    40
    serious Num Affected
    12
    serious Num At Risk
    40
    title
    Adenoid Cystic Carcinoma
  2. description
    Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    8
    serious Num At Risk
    14
    title
    Non Adenoid Cystic Carcinoma
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Abdominal distension
  2. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Activated partial thromboplastin time prolonged
  3. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      14
    term
    Alanine aminotransferase increased
  4. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Alkaline phosphatase increased
  5. organ System
    Immune system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Allergic reaction
  6. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Allergic rhinitis
  7. organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Alopecia
  8. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
    term
    Anemia
  9. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Anorexia
  10. organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Anxiety
  11. organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Arthralgia
  12. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
    term
    Aspartate aminotransferase increased
serious Events
  1. organ System
    Investigations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Alanine aminotransferase increased
  2. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Anorexia
  3. organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cauda equina syndrome
  4. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Chest pain
  5. organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Confusion
  6. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Death
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Dysphagia
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Dyspnea
  9. organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Hyperglycemia
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Hypoxia
  11. organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Infections and infestations
  12. organ System
    Eye disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Loss of vision
time Frame
Up to 5 years

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Preserved source evidence · Not medical advice