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NCT00045630 · OUTCOME

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

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium · Source last updated 2013-05-27

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 at weeks 1, 2, 4, 5, 7, 8, and following surgery

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 who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Groups in this outcome

Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery

Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.

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

Analysis denominator · Participants

GroupSource count
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery74

Reported measurements

Abnormal troponin I (cTnI)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Allergic reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery2Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery5Not reportedNot reportedNot reportedNot reported
Bilirubin increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Cardiac ischemia/infarction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Creatinine increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Diarrhea without colostomy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery2Not reportedNot reportedNot reportedNot reported
Duodenal ulcer
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Fatigue/malaise/lethargy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery3Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery2Not reportedNot reportedNot reportedNot reported
GI-other
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Hemolysis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Incontinence
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Infection with 3-4 neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery2Not reportedNot reportedNot reportedNot reported
Infection, unk ANC
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery2Not reportedNot reportedNot reportedNot reported
Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery22Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Melena/ GI bleeding
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Neutropenia/granulocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery41Not reportedNot reportedNot reportedNot reported
SGPT (ALT) increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery13Not reportedNot reportedNot reportedNot reported
Ureteral obstruction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Urinary tr infect w/ neutrop
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Urinary tr infect w/o neutrop
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Abnormal troponin I (cTnI)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Allergic reaction
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bilirubin increase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cardiac ischemia/infarction
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Creatinine increase
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Diarrhea without colostomy
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Duodenal ulcer
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dyspnea
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Fatigue/malaise/lethargy
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Febrile neutropenia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    GI-other
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    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 receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
    id
    OG000
    title
    Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
param Type
NUMBER
population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
reporting Status
POSTED
time Frame
Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
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