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NCT02042443 · ADVERSE EVENTS

Adverse events

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery · Source last updated 2017-09-12

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 2 years
Other-event reporting threshold
5%

Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trametinib

Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

13 / 2321 / 23Not reported / Not reported
Chemotherapy

Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

1 / 2019 / 20Not reported / Not reported

Group identifiers: EG000: Trametinib · EG001: Chemotherapy

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Esophageal varices hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastric hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastric ulcer
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastrointestinal disorders-Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Obstruction gastric
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Hepatobiliary disorders-Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Infections and infestations-Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Sepsis

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
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Ear and labyrinth disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Hearing impaired
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Watering eyes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Bloating
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      20
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      20
    term
    Diarrhea
Complete source fields
description
Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.
event Groups
  1. description
    Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    23
    serious Num Affected
    13
    serious Num At Risk
    23
    title
    Trametinib
  2. description
    Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    20
    serious Num Affected
    1
    serious Num At Risk
    20
    title
    Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Ear and labyrinth disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Hearing impaired
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    term
    Watering eyes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Bloating
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      20
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      20
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Esophageal varices hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastric hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastric ulcer
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Gastrointestinal disorders-Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Obstruction gastric
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Hepatobiliary disorders-Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Infections and infestations-Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    term
    Sepsis
time Frame
Up to 2 years

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Preserved source evidence · Not medical advice