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NCT02097134 · OUTCOME

Number of Patients Experiencing Feasibility Failure

Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma · Source last updated 2023-10-13

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
Up to 4 months

What was measured

Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment.

Analysis population: All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome

Groups in this outcome

Melphalan

Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Melphalan: Given IA

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

Analysis denominator · Participants

GroupSource count
Melphalan12

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melphalan4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment.
groups
  1. description
    Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Melphalan: Given IA
    id
    OG000
    title
    Melphalan
param Type
NUMBER
population Description
All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome
reporting Status
POSTED
time Frame
Up to 4 months
title
Number of Patients Experiencing Feasibility Failure
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice