NCT02042443 · OUTCOME

Overall Survival

Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery · Source last updated 2017-09-12

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: Up to 2 years from registration

What was measured

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Analysis population: Eligible and analyzable patients.

Groups in this outcome

Trametinib

Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Chemotherapy

Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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
Trametinib	24
Chemotherapy	20

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trametinib	4.3	Not reported	3.1	5.1	Not reported
Chemotherapy	7.9	Not reported	3.2	14.6	Not reported

Source statistical analyses

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

ci Lower Limit
1.01
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.03
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.05
param Type
Hazard Ratio (HR)
param Value
2.02
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
1.01
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.03
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.05
param Type
Hazard Ratio (HR)
param Value
2.02
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
3.1
upper Limit
5.1
value
4.3
group Id
OG001
lower Limit
3.2
upper Limit
14.6
value
7.9

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
20
units
Participants

description

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

dispersion Type

95% Confidence Interval

groups

description
Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Trametinib
description
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
OG001
title
Chemotherapy

param Type

MEDIAN

population Description

Eligible and analyzable patients.

reporting Status

POSTED

time Frame

Up to 2 years from registration

title

Overall Survival

type

PRIMARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice