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NCT00789958 · OUTCOME

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

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct · Source last updated 2018-04-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

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.

Groups in this outcome

Adjuvant Chemotherapy + Chemoradiotherapy

Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

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

Analysis denominator · Participants

GroupSource count
Adjuvant Chemotherapy + Chemoradiotherapy79

Reported measurements

Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Cardiac troponin I (cTnI)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy6Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy4Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Hemorrhage, GI - Duodenum
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Hemorrhage, GI - Lower GI NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Lung Infection w/normal ANC or Gr 1-2 neutrophils
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Skin Infection w/normal ANC or Gr 1-2 neutrophils
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Infection-Other (Specify)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy5Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy6Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis (clinical exam) - Oral cavity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy2Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy35Not reportedNot reportedNot reportedNot reported
Phosphate, serum-low (hypophosphatemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy2Not reportedNot reportedNot reportedNot reported
Potassium, serum-low (hypokalemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy2Not reportedNot reportedNot reportedNot reported
Rash/desquamation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Rash: hand-foot skin reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy10Not reportedNot reportedNot reportedNot reported
Sodium, serum-low (hyponatremia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Syncope (fainting)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Thrombosis/embolism (vascular access-related)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Thrombosis/thrombus/embolism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Ulcer, GI - Duodenum
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Ventricular arrhythmia - Ventricular tachycardia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anorexia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cardiac troponin I (cTnI)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Constipation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dehydration
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Fatigue (asthenia, lethargy, malaise)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile neutropenia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemoglobin
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemorrhage, GI - Duodenum
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemorrhage, GI - Lower GI NOS
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypotension
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Lung Infection w/normal ANC or Gr 1-2 neutrophils
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    units
    Participants
description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
groups
  1. description
    Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
    id
    OG000
    title
    Adjuvant Chemotherapy + Chemoradiotherapy
param Type
NUMBER
population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
reporting Status
POSTED
time Frame
Up to 5 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-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice