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NCT00770120 · OUTCOME

Frequency and Severity of Toxicities

S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery · Source last updated 2020-03-06

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
Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.

Analysis population: Number of Subjects With Greater Than Grade 2 Toxicity

Groups in this outcome

Everolimus

Daily oral Everolimus 10 mg/day

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

Analysis denominator · Participants

GroupSource count
Everolimus59

Reported measurements

Anorexia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Confusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Dehydration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus2Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Dyspnea (shortness of breath)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus3Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus6Not reportedNot reportedNot reportedNot reported
Glucose, serum-high (hyperglycemia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus3Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus4Not reportedNot reportedNot reportedNot reported
INR (of prothrombin time)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Infection with unknown ANC - Lung (pneumonia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus3Not reportedNot reportedNot reportedNot reported
Left ventricular systolic dysfunction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus2Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis (clinical exam) - Oral cavity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Mucositis/stomatitis (functional/symp) - Oral cav
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Muscle weakness, not d/t neuropathy - body/general
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus2Not reportedNot reportedNot reportedNot reported
Pneumonitis/pulmonary infiltrates
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus2Not reportedNot reportedNot reportedNot reported
Rash/desquamation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus1Not reportedNot reportedNot reportedNot reported
Triglyceride, serum-high (hypertriglyceridemia)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus2Not 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
    Confusion
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Dehydration
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Dyspnea (shortness of breath)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Fatigue (asthenia, lethargy, malaise)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Glucose, serum-high (hyperglycemia)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hemoglobin
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    INR (of prothrombin time)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Infection with unknown ANC - Lung (pneumonia)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Left ventricular systolic dysfunction
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
groups
  1. description
    Daily oral Everolimus 10 mg/day
    id
    OG000
    title
    Everolimus
param Type
NUMBER
population Description
Number of Subjects With Greater Than Grade 2 Toxicity
reporting Status
POSTED
time Frame
Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.
title
Frequency and Severity of Toxicities
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice