NCT03941860 · OUTCOME

Presence, Frequency, Interference, Amount, and/or Severity of Select Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial · Source last updated 2025-05-23

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Assessed every cycle up to cycle 25

What was measured

NCI PRO-CTCAE items will be administered. There are 80 symptomatic AE terms included in the PRO-CTCAE library. Items correspond to 5 attributes measured \[frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)\] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. For each attribute, recall is the past 7 days. Attributes measured for each symptomatic AE varies and comprise the PRO-CTCAE item library. For this study, 23 symptomatic AEs summing to 38 items have been selected as presented below. There are 10 symptomatic AEs assessed using one item, 11 symptomatic AEs assessed using two items, and 6 symptomatic AEs assessed using three items. The types of items in order of prevalence include severity, interference, frequency, present/not present, and amount. T

Groups in this outcome

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

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

denom Units Selected: Participants
description: NCI PRO-CTCAE items will be administered. There are 80 symptomatic AE terms included in the PRO-CTCAE library. Items correspond to 5 attributes measured \[frequency (F), severity (S), interference (I), presence/absence (P) and amount (A)\] based on multiple choice questions. Response for each attribute except P which is binary is on a 5-point Likert scale with 5 indicating 'almost constantly' frequency, 'very severe' severity, 'very much' amount or 'very much' interference. For each attribute, recall is the past 7 days. Attributes measured for each symptomatic AE varies and comprise the PRO-CTCAE item library. For this study, 23 symptomatic AEs summing to 38 items have been selected as presented below. There are 10 symptomatic AEs assessed using one item, 11 symptomatic AEs assessed using two items, and 6 symptomatic AEs assessed using three items. The types of items in order of prevalence include severity, interference, frequency, present/not present, and amount. T
reporting Status: NOT_POSTED
time Frame: Assessed every cycle up to cycle 25
title: Presence, Frequency, Interference, Amount, and/or Severity of Select Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE)
type: OTHER_PRE_SPECIFIED

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

Preserved source evidence · Not medical advice