NCT03206177 · OUTCOME

Proportion of Patients With Completion of 4 Cycles of CT + GB

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary · Source last updated 2024-08-07

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

Measure: NUMBER
Unit: proportion of patients
Interval / dispersion: 90% Confidence Interval
Time frame: 2 years

What was measured

Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.

Analysis population: Evaluable patients will be defined as patients who receive at least four cycles of study treatment.

Groups in this outcome

Paclitaxel/Carboplatin + Galunisertib

Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)

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
Paclitaxel/Carboplatin + Galunisertib	23

Reported measurements

Source class 1

Values in proportion of patients · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Paclitaxel/Carboplatin + Galunisertib	0.7826	Not reported	0.5961	0.9102	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.5961
upper Limit
0.9102
value
0.7826

denoms

counts
group Id
OG000
value
23
units
Participants

description

Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.

dispersion Type

90% Confidence Interval

groups

description
Galunisertib: Galunisertib 150mg po BID day 4-17 Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
id
OG000
title
Paclitaxel/Carboplatin + Galunisertib

param Type

NUMBER

population Description

Evaluable patients will be defined as patients who receive at least four cycles of study treatment.

reporting Status

POSTED

time Frame

2 years

title

Proportion of Patients With Completion of 4 Cycles of CT + GB

type

PRIMARY

unit Of Measure

proportion of patients

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

Preserved source evidence · Not medical advice