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NCT03480750 · OUTCOME

Percentage of Participants With Measurable Tumor Treatment Response Assessed by RECIST Criteria 1.1

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer · Source last updated 2020-11-10

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
176 days

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan

Analysis population: Two participants who declined any of the study agents after enrollment or declined the initial chemotherapy drug after a 7-day course of trientine were deemed ineligible for this analysis. According the protocol for this secondary outcome, all participants were not described separately.

Groups in this outcome

Trientine With Chemotherapy

trientine dihydrochloride PO daily (in different dose levels) plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (in different dose levels) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

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

Analysis denominator · Participants

GroupSource count
Trientine With Chemotherapy16

Reported measurements

Clinical benefit rates
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trientine With Chemotherapy43.8Not reportedNot reportedNot reportedNot reported
Response rates
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trientine With Chemotherapy25.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        43.8
    title
    Clinical benefit rates
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        25.0
    title
    Response rates
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan
groups
  1. description
    trientine dihydrochloride PO daily (in different dose levels) plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (in different dose levels) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    OG000
    title
    Trientine With Chemotherapy
param Type
NUMBER
population Description
Two participants who declined any of the study agents after enrollment or declined the initial chemotherapy drug after a 7-day course of trientine were deemed ineligible for this analysis. According the protocol for this secondary outcome, all participants were not described separately.
reporting Status
POSTED
time Frame
176 days
title
Percentage of Participants With Measurable Tumor Treatment Response Assessed by RECIST Criteria 1.1
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice