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NCT04099277 · OUTCOME

Duration of Response (DoR)

A Study of LY3435151 in Participants With Solid Tumors · Source last updated 2021-08-31

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)

What was measured

DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Analysis population: Zero participants were analyzed. The study was terminated early and no data was collected.

Groups in this outcome

10 mg LY3435151

Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.

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

Analysis denominator · Participants

GroupSource count
10 mg LY34351510

Reported measurements

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

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
groups
  1. description
    Participants received 10 mg dose of LY3435151 via intravenous (IV) as an IV push or IV bolus infusion.
    id
    OG000
    title
    10 mg LY3435151
population Description
Zero participants were analyzed. The study was terminated early and no data was collected.
reporting Status
POSTED
time Frame
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)
title
Duration of Response (DoR)
type
SECONDARY

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

Preserved source evidence · Not medical advice