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NCT01282463 · OUTCOME

Number of Participants With Serum Anti-Icrucumab Antibody Assessment

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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
Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose

What was measured

A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.

Analysis population: Zero participants analyzed. Data not collected.

Groups in this outcome

Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

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

Analysis denominator · Participants

GroupSource count
Docetaxel + Icrucumab0

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
A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
    id
    OG000
    title
    Docetaxel + Icrucumab
population Description
Zero participants analyzed. Data not collected.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
title
Number of Participants With Serum Anti-Icrucumab Antibody Assessment
type
SECONDARY

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

Preserved source evidence · Not medical advice