NCT02435433 · OUTCOME

Time to Radiographic Progression

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From Randomization to Objective Progression (Up to 28 Months)

What was measured

Time to radiographic progression is defined as the time from the date of randomization to the date of first observation of objective progression.

Analysis population: All randomized participants.

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.

Placebo + BSC

Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.

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	197
Placebo + BSC	95

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ramucirumab + BSC	3.02	Not reported	2.79	4.17	Not reported
Placebo + BSC	1.61	Not reported	1.45	2.73	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.313
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.582
estimate Comment
Stratified analysis
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.427
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.313
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.582
estimate Comment
Stratified analysis
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.427
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
2.79
upper Limit
4.17
value
3.02
group Id
OG001
lower Limit
1.45
upper Limit
2.73
value
1.61

denoms

counts
group Id
OG000
value
197
group Id
OG001
value
95
units
Participants

description

Time to radiographic progression is defined as the time from the date of randomization to the date of first observation of objective progression.

dispersion Type

95% Confidence Interval

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
description
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
id
OG001
title
Placebo + BSC

param Type

MEDIAN

population Description

All randomized participants.

reporting Status

POSTED

time Frame

From Randomization to Objective Progression (Up to 28 Months)

title

Time to Radiographic Progression

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice