NCT02426125 · OUTCOME

Number of Participants With Anti-Ramucirumab Antibodies

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer · Source last updated 2023-08-21

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: 29.7 Months

What was measured

Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.

Analysis population: All randomized participants who received at least one dose of study drug at baseline and post-baseline.

Groups in this outcome

Ramucirumab + Docetaxel

Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo + Docetaxel

Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

Group	Source count
Ramucirumab + Docetaxel	199
Placebo + Docetaxel	213

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + Docetaxel	3	Not reported	Not reported	Not reported	Not reported
Placebo + Docetaxel	8	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
8

denoms

counts
group Id
OG000
value
199
group Id
OG001
value
213
units
Participants

description

Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.

groups

description
Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
id
OG000
title
Ramucirumab + Docetaxel
description
Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
id
OG001
title
Placebo + Docetaxel

param Type

COUNT_OF_PARTICIPANTS

population Description

All randomized participants who received at least one dose of study drug at baseline and post-baseline.

reporting Status

POSTED

time Frame

29.7 Months

title

Number of Participants With Anti-Ramucirumab Antibodies

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice