NCT02426125 · OUTCOME

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

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: GEOMETRIC_MEAN
Unit: microgram/milliliter (μg/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 and Cycle 9, Day 1: Predose, Postdose

What was measured

Cmax of Ramucirumab at the end of ramucirumab infusion.

Analysis population: All randomized participants who had evaluable PK data.

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.

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	209

Reported measurements

Cycle 1

Analysis denominator · Participants

Group	Source count
Ramucirumab + Docetaxel	209

Values in microgram/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + Docetaxel	199	28	Not reported	Not reported	Not reported

Cycle 9

Analysis denominator · Participants

Group	Source count
Ramucirumab + Docetaxel	22

Values in microgram/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + Docetaxel	265	29	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
28
value
199
denoms
counts
group Id
OG000
value
209
units
Participants
title
Cycle 1
categories
measurements
group Id
OG000
spread
29
value
265
denoms
counts
group Id
OG000
value
22
units
Participants
title
Cycle 9

denoms

counts
group Id
OG000
value
209
units
Participants

description

Cmax of Ramucirumab at the end of ramucirumab infusion.

dispersion Type

Geometric Coefficient of Variation

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

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who had evaluable PK data.

reporting Status

POSTED

time Frame

Cycle 1 and Cycle 9, Day 1: Predose, Postdose

title

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

type

SECONDARY

unit Of Measure

microgram/milliliter (μg/mL)

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

Preserved source evidence · Not medical advice