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NCT00022633 · OUTCOME

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

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract · Source last updated 2016-08-11

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
Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.

What was measured

Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Analysis population: Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded

Groups in this outcome

Paclitaxel + Gemcitabine

Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)

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

Analysis denominator · Participants

GroupSource count
Paclitaxel + Gemcitabine51

Reported measurements

Abdominal pain/cramping
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Acidosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Allergic reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine6Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine3Not reportedNot reportedNot reportedNot reported
Bone pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Cardiac ischemia/infarction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Chest pain,not cardio or pleur
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Confusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Constipation/bowel obstruction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Creatinine increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Diarrhea without colostomy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Dizziness/light headedness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Dyspepsia/heartburn
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine6Not reportedNot reportedNot reportedNot reported
Edema
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Fatigue/malaise/lethargy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine8Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Gastric ulcer
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine3Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Infection w/o 3-4 neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Infection with 3-4 neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine3Not reportedNot reportedNot reportedNot reported
Infection, unk ANC
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine6Not reportedNot reportedNot reportedNot reported
Muscle weakness (not neuro)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Myalgia/arthralgia, NOS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine3Not reportedNot reportedNot reportedNot reported
Neuropathic pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Neutropenia/granulocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine26Not reportedNot reportedNot reportedNot reported
PRBC transfusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine10Not reportedNot reportedNot reportedNot reported
Pain-other
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine3Not reportedNot reportedNot reportedNot reported
Pleural effusions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Pneumonitis/infiltrates
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Renal failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Respiratory infect w/ neutrop
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
SGOT (AST) increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Sensory neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine3Not reportedNot reportedNot reportedNot reported
Supraventricular arrhythmia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Thrombosis/embolism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Urinary tr infect w/ neutrop
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Urinary tr infect w/o neutrop
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Ventricular arrhythmia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine1Not reportedNot reportedNot reportedNot reported
Weakness (motor neuropathy)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paclitaxel + Gemcitabine2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Abdominal pain/cramping
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Acidosis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Allergic reaction
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Anorexia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bone pain
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cardiac ischemia/infarction
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Chest pain,not cardio or pleur
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Confusion
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Constipation/bowel obstruction
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Creatinine increase
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dehydration
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
groups
  1. description
    Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
    id
    OG000
    title
    Paclitaxel + Gemcitabine
param Type
NUMBER
population Description
Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded
reporting Status
POSTED
time Frame
Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.
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