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NCT02568449 · OUTCOME

Incidence of Grade 3-4 Toxicity

Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent · Source last updated 2021-12-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

Number of participants with grade 3 or grade 4 for each type of toxicity encountered, using all toxicity evaluable patients.

Groups in this outcome

Treatment (Nintedanib)

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO

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

Analysis denominator · Participants

GroupSource count
Treatment (Nintedanib)20

Reported measurements

Dyspnea (shortness of breath)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)5Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)4Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)2Not reportedNot reportedNot reportedNot reported
Syncope (fainting)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
pulmonary/upper respiratory- other, acute respiratory event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Thrombosis/thrombus/embolism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Encephalopathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Pericardial effusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Pain - Chest wall
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Ascites (non-malignant)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Edema: trunk/genital
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Supraventricular and nodal arrhythmia - Atrial fibrillation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nintedanib)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Dyspnea (shortness of breath)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Lymphopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hypoxia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Syncope (fainting)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    pulmonary/upper respiratory- other, acute respiratory event
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Thrombosis/thrombus/embolism
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Encephalopathy
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pericardial effusion
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pain - Chest wall
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Ascites (non-malignant)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Edema: trunk/genital
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Supraventricular and nodal arrhythmia - Atrial fibrillation
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Number of participants with grade 3 or grade 4 for each type of toxicity encountered, using all toxicity evaluable patients.
groups
  1. description
    Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO
    id
    OG000
    title
    Treatment (Nintedanib)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 1 year
title
Incidence of Grade 3-4 Toxicity
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice