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NCT02042443 · OUTCOME

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Analysis population: Eligible patients who received any treatment and were assessed for adverse events are included in this summary. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.

Groups in this outcome

Trametinib

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Trametinib23
Chemotherapy20

Reported measurements

Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Ascites
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Colitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Gastric ulcer
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Gastritis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Generalized muscle weakness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Hepatobiliary disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Infections and infestations - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Pain in extremity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Palmar-plantar erythrodysesthesia syndrome
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib0Not reportedNot reportedNot reportedNot reported
Chemotherapy1Not reportedNot reportedNot reportedNot reported
Sepsis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Thromboembolic event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Urinary tract infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trametinib1Not reportedNot reportedNot reportedNot reported
Chemotherapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Alanine aminotransferase increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Ascites
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Aspartate aminotransferase increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Blood bilirubin increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Colitis
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Fatigue
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Gastric ulcer
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Gastritis
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Gastrointestinal disorders - Other, specify
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Generalized muscle weakness
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Hepatobiliary disorders - Other, specify
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
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
    OG000
    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
    OG001
    title
    Chemotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.
reporting Status
POSTED
time Frame
Up to 2 years
title
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice