NCT02601209 · OUTCOME

The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period)

Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma · Source last updated 2022-08-23

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 4 months

What was measured

The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below.

Analysis population: Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen )

Groups in this outcome

Phase II - Analysis Group 2 MLN0128

Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.

Phase II - Analysis Group 2 Pazopanib

Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.

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
Phase II - Analysis Group 2 MLN0128	55
Phase II - Analysis Group 2 Pazopanib	56

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase II - Analysis Group 2 MLN0128	28	Not reported	Not reported	Not reported	Not reported
Phase II - Analysis Group 2 Pazopanib	38	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
28
group Id
OG001
value
38

denoms

counts
group Id
OG000
value
55
group Id
OG001
value
56
units
Participants

description

The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below.

groups

description
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
id
OG000
title
Phase II - Analysis Group 2 MLN0128
description
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
id
OG001
title
Phase II - Analysis Group 2 Pazopanib

param Type

COUNT_OF_PARTICIPANTS

population Description

Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen )

reporting Status

POSTED

time Frame

Up to 4 months

title

The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice