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NCT00140855 · OUTCOME

Number of Subjects Reporting Adverse Events (AEs)

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 13 weeks

What was measured

All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).

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
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
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
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 13 weeks
title
Number of Subjects Reporting Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice