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NCT00140855 · OUTCOME

Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).

A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma · Source last updated 2022-10-12

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 10 weeks

What was measured

Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.

Analysis population: All subjects who entered the study.

Groups in this outcome

Ipilimumab

Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.

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

Analysis denominator · Participants

GroupSource count
Ipilimumab6

Reported measurements

Source class 1

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab0Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab0Not reportedNot reportedNot reportedNot reported

SD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab0Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      CR
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      PR
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      SD
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      PD
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
groups
  1. description
    Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
    id
    OG000
    title
    Ipilimumab
param Type
COUNT_OF_PARTICIPANTS
population Description
All subjects who entered the study.
reporting Status
POSTED
time Frame
up to 10 weeks
title
Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice