NCT02435433 · OUTCOME

PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein · Source last updated 2023-01-20

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

Measure: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Weeks 0, 2, 6, 12 and 18, Day 1; 1 hour to 1.5 hours Post End of Infusion (14 day-Cycles)

What was measured

PK Cmax of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.

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

Groups in this outcome

Ramucirumab + BSC

8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue 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 + BSC	195

Reported measurements

Week 0

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + BSC	156	22	Not reported	Not reported	Not reported

Week 2

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + BSC	181	24	Not reported	Not reported	Not reported

Week 6

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + BSC	205	24	Not reported	Not reported	Not reported

Week 12

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + BSC	221	24	Not reported	Not reported	Not reported

Week 18

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + BSC	228	22	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
22
value
156
title
Week 0
categories
measurements
group Id
OG000
spread
24
value
181
title
Week 2
categories
measurements
group Id
OG000
spread
24
value
205
title
Week 6
categories
measurements
group Id
OG000
spread
24
value
221
title
Week 12
categories
measurements
group Id
OG000
spread
22
value
228
title
Week 18

denoms

counts
group Id
OG000
value
195
units
Participants

description

PK Cmax of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.

dispersion Type

Geometric Coefficient of Variation

groups

description
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
id
OG000
title
Ramucirumab + BSC

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least one dose of study drug.

reporting Status

POSTED

time Frame

Weeks 0, 2, 6, 12 and 18, Day 1; 1 hour to 1.5 hours Post End of Infusion (14 day-Cycles)

title

PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice