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NCT04191499 · OUTCOME

Time to Deterioration (TTD) in Pain

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer · Source last updated 2026-06-15

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
From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years)

What was measured

TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. A ≥2-point change is defined as clinically meaningful difference.

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
anticipated Posting Date
2031-09
denom Units Selected
Participants
description
TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. A ≥2-point change is defined as clinically meaningful difference.
reporting Status
NOT_POSTED
time Frame
From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years)
title
Time to Deterioration (TTD) in Pain
type
SECONDARY

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

Preserved source evidence · Not medical advice