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NCT00100789 · OUTCOME

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

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer · Source last updated 2012-10-01

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

Measure
NUMBER
Unit
Participants with a given type of AE
Interval / dispersion
Not reported
Time frame
Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.

What was measured

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. 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 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 were deemed to be related to protocol treatment are included.

Groups in this outcome

Gemcitabine and Paclitaxel

Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

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 and Paclitaxel63

Reported measurements

Allergic reaction/hypersensitivity
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel2Not reportedNot reportedNot reportedNot reported
Dyspnea (shortness of breath)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel2Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel8Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel3Not reportedNot reportedNot reportedNot reported
Glucose, serum-high (hyperglycemia)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel2Not reportedNot reportedNot reportedNot reported
Hemorrhage, pulmonary/upper respiratory - Nose
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel2Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel3Not reportedNot reportedNot reportedNot reported
Memory impairment
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis (functional/symp) - Oral cav
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Muscle weakness, not d/t neuropathy - body/general
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Neuropathy: motor
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel3Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel7Not reportedNot reportedNot reportedNot reported
Pain - Bone
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Pain-Other (Specify)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel2Not reportedNot reportedNot reportedNot reported
Pneumonitis/pulmonary infiltrates
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Rash/desquamation
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Rash: acne/acneiform
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Sodium, serum-low (hyponatremia)
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel3Not reportedNot reportedNot reportedNot reported
Thrombosis/thrombus/embolism
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants with a given type of AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Allergic reaction/hypersensitivity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anorexia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dehydration
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Diarrhea
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Dyspnea (shortness of breath)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Fatigue (asthenia, lethargy, malaise)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Febrile neutropenia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Glucose, serum-high (hyperglycemia)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hemoglobin
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemorrhage, pulmonary/upper respiratory - Nose
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypotension
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. 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 Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
    id
    OG000
    title
    Gemcitabine and Paclitaxel
param Type
NUMBER
population Description
Eligible patients who 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 were deemed to be related to protocol treatment are included.
reporting Status
POSTED
time Frame
Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
title
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
type
SECONDARY
unit Of Measure
Participants with a given type of AE

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

Preserved source evidence · Not medical advice